PIK3CA mutation — biomarker · CancerIndex

Biomarker · Gene alteration

PIK3CA mutation

Activating PIK3CA mutations detected in tumor tissue or plasma; used as a predictive marker for PI3K-pathway inhibitors, notably in hormone receptor-positive breast cancer.

CI-BIO-00000006PIK3CA graph →NCIt C96271 Tumor-agnostic · 2 approval rows

Also calledPIK3CA-mutated · PIK3CA-altered · H1047R · E545K

Tissue-agnostic indications

Approval rows flagged tumor-agnostic (2)

Trametinib US FDA · Mar 16, 2023 · drug in derived setRegulatory approved
Trametinib US FDA · May 29, 2013 · drug in derived setRegulatory approved

The flag is the source's (openFDA label text), never inferred; the full indication text of each row is in the Approvals section below.

Derived

Associated cancers (18)

Cancers mapped in ACCEPTED CIViC predictive, prognostic or diagnostic items whose variant (molecular markers) or gene (gene-level markers) is in this biomarker's scope. Counts by type and native level; each row links to the cancer's evidence tab.

Computedrule biomarker-links-v1

Cancer	Items	Predictive	Prognostic	Diagnostic	Levels A / B / C / D / E
HER2-Positive Breast Carcinoma	25	25	—	—	0 / 5 / 1 / 19 / 0
Malignant Breast Neoplasm	22	18	4	—	6 / 7 / 0 / 9 / 0
Malignant Colorectal Neoplasm	21

Derived

Drugs with predictive evidence (50)

Therapies named in in-scope PREDICTIVE CIViC items, plus targets of PREDICTS_RESPONSE_TO knowledge edges from in-scope variants. Sensitivity and resistance are counted separately and never merged into a verdict.

Computedrule biomarker-links-v1

Drug	CIViC items	Sensitivity	Resistance	Best level	Edges (S / R)	Cancer context
TrastuzumabMonoclonal Antibody	11	1	10	B	1 / 10	HER2-Positive Breast Carcinoma, Malignant Breast Neoplasm
CetuximabMonoclonal Antibody	11	1	10	B	1 / 6	Malignant Colorectal Neoplasm, Malignant Head and Neck Neoplasm
PictilisibSmall Molecule	9	9	—	D	7 / 0	Cervical Carcinoma, HER2-Positive Breast Carcinoma, Malignant Breast Neoplasm, Malignant Endometrial Neoplasm +2
FulvestrantSmall Molecule	8	7	1	A	7 / 1	HER2-Positive Breast Carcinoma, Malignant Breast Neoplasm
CapivasertibSmall Molecule	7	7	—	A	7 / 0	HER2-Positive Breast Carcinoma, Malignant Breast Neoplasm, Malignant Gastric Neoplasm, Malignant Neoplasm
DactolisibSmall Molecule	7	5	2	D	5 / 0	HER2-Positive Breast Carcinoma, Lung Adenocarcinoma, Malignant Head and Neck Neoplasm
LapatinibSmall Molecule	6	1	5	B	1 / 5	HER2-Positive Breast Carcinoma
AlpelisibSmall Molecule	5	5	—	A	5 / 0	Malignant Breast Neoplasm, Malignant Head and Neck Neoplasm, Malignant Neoplasm
PanitumumabMonoclonal Antibody	5	—	5	B	0 / 3	Malignant Colorectal Neoplasm
PalbociclibSmall Molecule	4	3	1	A	3 / 1	Malignant Breast Neoplasm
AspirinSmall Molecule	3	3	—	B	3 / 0	Head and Neck Squamous Cell Carcinoma, Malignant Colorectal Neoplasm
CisplatinSmall Molecule	3	1	2	D	1 / 2	Cervical Carcinoma, Malignant Cervical Neoplasm
EverolimusSmall Molecule	3	3	—	B	3 / 0	HER2-Positive Breast Carcinoma, Malignant Breast Neoplasm
GefitinibSmall Molecule	3	—	3	B	0 / 3	Lung Adenocarcinoma, Lung Non-Small Cell Carcinoma
VemurafenibSmall Molecule	3	1	2	D	1 / 2	Malignant Colorectal Neoplasm, Melanoma
TaselisibSmall Molecule	3	3	—	C	2 / 0	Head and Neck Squamous Cell Carcinoma, Malignant Neoplasm
Trastuzumab EmtansineAdc	3	—	3	B	—	HER2-Positive Breast Carcinoma
Akt Inhibitor MK2206	2	2	—	D	2 / 0	Malignant Breast Neoplasm, Malignant Colorectal Neoplasm
ErlotinibSmall Molecule	2	—	2	B	0 / 2	Lung Adenocarcinoma, Lung Non-Small Cell Carcinoma
InavolisibSmall Molecule	2	2	—	A	2 / 0	Malignant Breast Neoplasm
Phosphatidylinositide 3-Kinase Inhibitor	2	2	—	D	2 / 0	Malignant Breast Neoplasm
PI3Ka/Di	2	2	—	D	2 / 0	HER2-Positive Breast Carcinoma, Malignant Breast Neoplasm
IrinotecanSmall Molecule	2	—	2	B	0 / 1	Malignant Colorectal Neoplasm
TemsirolimusSmall Molecule	2	2	—	B	1 / 0	Malignant Endometrial Neoplasm, Malignant Thyroid Gland Neoplasm
TanespimycinSmall Molecule	2	2	—	D	—	Malignant Head and Neck Neoplasm, Malignant Neoplasm
Anti-EGFR Monoclonal Antibody	1	—	1	B	0 / 1	Malignant Colorectal Neoplasm
ApitolisibSmall Molecule	1	1	—	C	1 / 0	Malignant Neoplasm
CabozantinibSmall Molecule	1	1	—	D	1 / 0	Malignant Colorectal Neoplasm
CapecitabineSmall Molecule	1	—	1	B	0 / 1	HER2-Positive Breast Carcinoma
CelecoxibSmall Molecule	1	1	—	B	1 / 0	Head and Neck Squamous Cell Carcinoma
CopanlisibSmall Molecule	1	1	—	B	1 / 0	Malignant Neoplasm
ErdafitinibSmall Molecule	1	—	1	C	0 / 1	Urothelial Carcinoma
Ionizing Radiotherapy	1	—	1	D	0 / 1	Malignant Cervical Neoplasm
IzorlisibSmall Molecule	1	1	—	D	1 / 0	Malignant Breast Neoplasm
MTOR Kinase Inhibitor PP242	1	1	—	D	1 / 0	Malignant Breast Neoplasm
PerifosineSmall Molecule	1	1	—	D	1 / 0	Malignant Thyroid Gland Neoplasm
PI-103Small Molecule	1	—	1	D	0 / 1	Malignant Breast Neoplasm
PI103	1	1	—	D	1 / 0	Lung Non-Small Cell Carcinoma
Radiation Therapy	1	1	—	D	1 / 0	Head and Neck Squamous Cell Carcinoma
RibociclibSmall Molecule	1	1	—	D	1 / 0	Malignant Breast Neoplasm
SapanisertibSmall Molecule	1	1	—	B	1 / 0	Solid Neoplasm
SulindacSmall Molecule	1	1	—	B	1 / 0	Head and Neck Squamous Cell Carcinoma
BevacizumabMonoclonal Antibody	1	—	1	B	—	Malignant Colorectal Neoplasm
Chemotherapy	1	—	1	B	—	Malignant Colorectal Neoplasm
FAC Regimen	1	—	1	B	—	Malignant Breast Neoplasm
FEC Regimen	1	—	1	B	—	Malignant Breast Neoplasm
OxaliplatinSmall Molecule	1	—	1	B	—	Malignant Colorectal Neoplasm
RidaforolimusSmall Molecule	1	1	—	B	—	Malignant Endometrial Neoplasm
TamoxifenSmall Molecule	1	1	—	B	—	—
TrametinibSmall Molecule	1	1	—	D	—	Malignant Head and Neck Neoplasm

Curatedcivic items and knowledge edges as curated at the source.

Curated evidence

Predictive evidence items (94)

ACCEPTED CIViC predictive items in scope, grouped by molecular profile and therapy with native level, direction and cancer context. 50 per page.

civicCuratedShowing 1–50 of 94 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
PIK3CA E545K17
Cisplatin + PictilisibCombination	Cervical CarcinomaALIAS	Predictive	D	Supports Sensitivity Response	3	accepted	EID2984 CaSki cells that are heterozygous for the PIK3CA-E545K mutation are more resistant to cisplatin or cisplatin plus radiation than either HeLa or SiHa cells that express only wild-type PIK3CA. Similarly… (full text at CIViC) PMID 27489350 · Arjumand et al., 2016 · Open in CIViC	civic
Dactolisib	HER2-Positive Breast CarcinomaALIAS	Predictive	D	Does Not Support Resistance	3	accepted	EID6213 This preclinical study tested the sensitivity of HER2-positive breast cancer cell line BT-474 (heterozygous for PIK3CA K111N) retrovirally transduced with PIK3CA E545K to NVP-BEZ235 (dactolisib; a dua… (full text at CIViC) PMID 19010894 · Eichhorn et al., 2008 · Open in CIViC	civic
Lapatinib	HER2-Positive Breast CarcinomaALIAS	Predictive	D	Supports Resistance	3	accepted	EID6207 This preclinical study tested, in vitro, the resistance to lapatinib (an anti-HER2 drug) of HER2-positive breast cancer cell lines (BT474 and SKBR3) retrovirally transduced with E545K. The study found… (full text at CIViC) PMID 19010894 · Eichhorn et al., 2008 · Open in CIViC	civic
Lapatinib + TrastuzumabCombination	HER2-Positive Breast CarcinomaALIAS	Predictive	D	Supports Resistance	3	accepted	EID6211 In a preclinical study, efficacy of lapatinib and trastuzumab was evaluated in vitro against HER2 amplified breast cancer cell lines BT474 (heterozygous for PIK3CA K111N) or SKBR3, retrovirally transd… (full text at CIViC) PMID 19010894 · Eichhorn et al., 2008 · Open in CIViC	civic
PI3Ka/Di	HER2-Positive Breast CarcinomaALIAS	Predictive	D	Supports Sensitivity Response	1	accepted	EID8017 As part of a preclinical study, the efficacy of PI3KA/Di—a selective inhibitor for the α (IC50 for p100α: 3nM) and δ (IC50 for p100δ: 20nM) subunits of class I PI3K—was evaluated for several cell line… (full text at CIViC) PMID 20453058 · O'Brien et al., 2010 · Open in CIViC	civic
Pictilisib	HER2-Positive Breast CarcinomaALIAS	Predictive	D	Supports Sensitivity Response	4	accepted	EID2062 This preclinical study tested the efficacy on several breast cancer cell lines of GDC-0941 (pictilisib), a selective inhibitor of all four isoforms of class I PI3-kinases at a range of IC50 values. Se… (full text at CIViC) PMID 20453058 · O'Brien et al., 2010 · Open in CIViC	civic
Trastuzumab	HER2-Positive Breast CarcinomaALIAS	Predictive	D	Supports Resistance	2	accepted	EID1453 PI3K mutant E545K was overexpressed in the trastuzumab sensitive HER2 BT474 breast cancer cell line, and significant resistance to trastuzumab was induced in comparison to control cells. PMID 18829560 · Serra et al., 2008 · Open in CIViC	civic
〃	HER2-Positive Breast CarcinomaALIAS	Predictive	D	Supports Resistance	3	accepted	EID6209 This preclinical study tested, in vitro, the resistance to trastuzumab (an anti-HER2 drug) of HER2-positive cell lines (BT474 and SKBR3) retrovirally transduced with E545K. The study found that the E5… (full text at CIViC) PMID 19010894 · Eichhorn et al., 2008 · Open in CIViC	civic
〃	HER2-Positive Breast CarcinomaALIAS	Predictive	D	Supports Resistance	2	accepted	EID8547 As part of a pre-clinical experiment, the efficacy of trastuzumab was evaluated against various HER2 positive cell lines. MCF7-neo/HER2 cell line harboring PIK3CA E545K was associated with resistance … (full text at CIViC) PMID 26920887 · Baselga et al., 2016 · Open in CIViC	civic
Trastuzumab Emtansine	HER2-Positive Breast CarcinomaALIAS	Predictive	D	Does Not Support Resistance	3	accepted	EID2036 As part of a pre-clinical experiment, the efficacy of ado-trastuzumab emtansine (T-DM1) was compared to that of trastuzumab against various HER2 positive cell lines. MCF7-neo/HER2 cell line harboring … (full text at CIViC) PMID 26920887 · Baselga et al., 2016 · Open in CIViC	civic
Gefitinib	Lung Adenocarcinoma	Predictive	D	Supports Resistance	2	accepted	EID1171 HCC827 cell lines harboring activated PI3K (HCC827 p110α E545K cells) were more resistant to gefitinib in vitro (IC50, 1 μM) compared with those harboring GFP alone (IC50, 0.01 μM). The presence of p1… (full text at CIViC) PMID 16906227 · Engelman et al., 2006 · Open in CIViC	civic
Erlotinib + GefitinibSubstitutes	Lung Adenocarcinoma	Predictive	C	Supports Resistance	2	accepted	EID1670 48 tumor samples from 41 patients with EGFR mutant lung adenocarcinoma that were resistant to tyrosine kinase inhibition underwent next generation sequencing (AmpliSeq Cancer Hotspot Panel (v2) failed… (full text at CIViC) PMID 27304188 · Belchis et al., 2016 · Open in CIViC	civic
PI103	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	2	accepted	EID2040 H460, a gefitinib-resistant NSCLC cell line harboring PIK3CA E545K (a PIK3CA activating mutation), was used to test the anti-tumor effects of PI103. Without treatment, H460 cells expressed high levels… (full text at CIViC) PMID 19513541 · Zou et al., 2009 · Open in CIViC	civic
Akt Inhibitor MK2206 + PictilisibSubstitutes	Malignant Breast Neoplasm	Predictive	D	Supports Sensitivity Response	3	accepted	EID710 PIK3CA E545K mutation increased sensitivity to AKT inhibitor MK-2206 and PI3K inhibitor GDC-0941 in a breast cancer cell line model. PMID 23888070 · Beaver et al., 2013 · Open in CIViC	civic
PI-103	Malignant Breast Neoplasm	Predictive	D	Supports Resistance	1	accepted	EID8008 As part of a preclinical study, the efficacy of PI-103 was evaluated for several cell lines of breast cancer. Sensitivity and resistance was categorized as less than and more than an IC50 of 1umol/L, … (full text at CIViC) PMID 20453058 · O'Brien et al., 2010 · Open in CIViC	civic
PI3Ka/Di	Malignant Breast Neoplasm	Predictive	D	Supports Sensitivity Response	1	accepted	EID8018 As part of a preclinical study, the efficacy of PI3KA/Di—a selective inhibitor for the α (IC50 for p100α: 3nM) and δ (IC50 for p100δ: 20nM) subunits of class I PI3K—was evaluated for several cell line… (full text at CIViC) PMID 20453058 · O'Brien et al., 2010 · Open in CIViC	civic
Pictilisib	Malignant Breast Neoplasm	Predictive	D	Supports Sensitivity Response	2	accepted	EID2034 This preclinical study tested the efficacy on several breast cancer cell lines of GDC-0941 (pictilisib), a selective inhibitor of all four isoforms of class I PI3-kinases over a range of IC50 values. … (full text at CIViC) PMID 20453058 · O'Brien et al., 2010 · Open in CIViC	civic
PIK3CA Mutation12
Aspirin + Celecoxib + SulindacSubstitutes	Head and Neck Squamous Cell Carcinoma	Predictive	B	Supports Sensitivity Response	3	accepted	EID7185 In this retrospective study, the impact of nonsteroidal anti-inflammatory drugs (NSAID) on survival in PIK3CA-altered HNSCC patients (N=266) was assessed. 37 of 266 (14%) patients harbored a mutation,… (full text at CIViC) PMID 30683736 · Hedberg et al., 2019 · Open in CIViC	civic
Radiation Therapy + TaselisibCombination	Head and Neck Squamous Cell Carcinoma	Predictive	D	Supports Sensitivity Response	3	accepted	EID1490 A panel of 26 HNSCC cell lines was tested for efficacy of the p110 alpha, delta and gamma isoform inhibitor taselisib (GDC-0032). Cell lines with PIK3CA mutation or amplification were the most sensiti… (full text at CIViC) PMID 26589432 · Zumsteg et al., 2016 · Open in CIViC	civic
Capecitabine
PIK3CA H1047R14
Taselisib	Head and Neck Squamous Cell Carcinoma	Predictive	D	Supports Sensitivity Response	2	accepted	EID1465 The Cal-33 HNSCC cell line with H1047R mutation was found to have a low antiproliferative IC50 value for the alpha, gamma and delta isoform-specific PI3K inhibitor taselisib. Increasing taselisib conc… (full text at CIViC) PMID 26589432 · Zumsteg et al., 2016 · Open in CIViC	civic
Capivasertib + LapatinibCombination	HER2-Positive Breast CarcinomaALIAS	Predictive	D	Supports Sensitivity Response	3	accepted	EID1506 The HER2 breast cancer cell line KPL4 with PIK3CA H1047R shows sub-optimal responses to trastuzumab and lapatinib, and was used to establish mouse xenografts. Treatment of mice with monotherapy of AZD… (full text at CIViC) PMID 22294718 · Davies et al., 2012 · Open in CIViC	civic
Capivasertib + Trastuzumab
PIK3CA H1047L + PIK3CA H1047R + PIK3CA H1047Y1
Alpelisib + FulvestrantCombination	Malignant Breast Neoplasm	Predictive	A	Supports Sensitivity Response	5	accepted	EID7318 In a phase 3 trial, patients with hormone receptor positive, HER2 receptor negative breast were allocated to alpelisib plus fulvestrant or placebo plus fulvestrant. Patients were enrolled into two coh… (full text at CIViC) PMID 31091374 · André et al., 2019 · Open in CIViC	civic
PIK3CA E545A + PIK3CA E545D + PIK3CA E545G + PIK3CA E545K1
Alpelisib + FulvestrantCombination	Malignant Breast Neoplasm	Predictive	A	Supports Sensitivity Response	4	accepted	EID7468 In a phase 3 trial, 572 patients with hormone receptor positive, HER2 receptor negative advanced breast cancer who previously received endocrine therapy were allocated to alpelisib plus fulvestrant or… (full text at CIViC) PMID 31091374 · André et al., 2019 · Open in CIViC	civic
AKT1 Mutation + PIK3CA Mutation + PTEN MutationPIK3CA PTEN AKT11
Capivasertib + FulvestrantCombination	Malignant Breast Neoplasm	Predictive	A	Supports Sensitivity Response	3	accepted	EID12020 In a phase 3 trial (NCT04305496) of 708 patients with advanced HR+ HER2- breast cancer, the combination of the AKT inhibitor capivasertib and the estrogen receptor degrader fulvestrant resulted in sig… (full text at CIViC) PMID 37256976 · Turner et al., 2023 · Open in CIViC	civic
PIK3CA E542K + PIK3CA E545K + PIK3CA H1047R1
FAC Regimen + FEC RegimenSubstitutes	Malignant Breast Neoplasm	Predictive	B	Does Not Support Resistance	3	accepted	EID6191 This study of 140 patients with stage II-III breast cancer assessed the response of patients with PIK3CA mutations to 6 months of preoperative chemotherapy. Exons 1, 9, and 20 of PIK3CA were screened… (full text at CIViC) PMID 18371219 · Liedtke et al., 2008 · Open in CIViC	civic
ESR1 Mutation + PIK3CA Mutation + RB1 MutationPIK3CA RB1 ESR11
Fulvestrant + PalbociclibCombination	Malignant Breast Neoplasm	Predictive	B	Supports Resistance	3	accepted	EID12045 In this phase III trial (PALOMA-3), patients with ER+, HER2- advanced breast cancer were treated with CDK4/6 inhibitors. Patients were randomized to receive palbociclib plus fulvestrant (P+F) or place… (full text at CIViC) PMID 30206110 · O'Leary et al., 2018 · Open in CIViC	civic
PIK3CA H1047D + PIK3CA H1047I + PIK3CA H1047L + PIK3CA H1047N + PIK3CA H1047P + PIK3CA H1047Q + PIK3CA H1047R + PIK3CA H1047T + PIK3CA H1047Y1
Fulvestrant + Inavolisib + PalbociclibCombination	Malignant Breast Neoplasm	Predictive	A	Supports Sensitivity Response	3	accepted	EID12533 The phase III INAVO120 trial (NCT04191499) in 325 patients with endocrine-resistant, PIK3CA-mutated HR⁺/HER2⁻ locally advanced or metastatic breast cancer evaluated inavolisib plus palbociclib and ful… (full text at CIViC) PMID 40845250 · Wedam et al., 2025 · Open in CIViC	civic
PIK3CA E545A + PIK3CA E545D + PIK3CA E545G + PIK3CA E545K + PIK3CA E545L + PIK3CA E545Q + PIK3CA E545R + PIK3CA E545V1
Fulvestrant + Inavolisib + PalbociclibCombination	Malignant Breast Neoplasm	Predictive	A	Supports Sensitivity Response	3	accepted	EID12534 The phase III INAVO120 trial (NCT04191499) in 325 patients with endocrine-resistant, PIK3CA-mutated HR⁺/HER2⁻ locally advanced or metastatic breast cancer evaluated inavolisib plus palbociclib and ful… (full text at CIViC) PMID 40845250 · Wedam et al., 2025 · Open in CIViC	civic

Regulatory

Approvals mentioning the linked drugs (500)

Approval records of the derived drug set, plus records whose indication text names this biomarker. Each record names its authority, jurisdiction, indication text and status — a drug approved in one jurisdiction for one indication is not 'approved' in general, and an approval listed here is not necessarily restricted to this biomarker.

Computedrule biomarker-links-v1

openfdaRegulatory50 approval records from 3 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Drug	Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
Trametinib	US FDA	Tumor-agnostic	the treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). • the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy.accelerated	approved	Mar 16, 2023	openfda
Trametinib	US FDA	Tumor-agnostic	the treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). • the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy.accelerated	approved	May 29, 2013	openfda

Health Canada DIN rows carry no indication text and only match by drug.

Clinical trials

Active trials (1,074)

Trials with an active ClinicalTrials.gov status, an intervention mapped to a derived drug and a condition mapped to an associated cancer. 542 recruiting · 278 active phase 3 · 5,253 in any status. Most recently updated first, 50 per page.

Computedrule biomarker-links-v1

clinicaltrialsPublishedShowing 1–50 of 1,074 active studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT04793958	Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10)	active not recruiting	Phase 3	461	Mirati Therapeutics Inc.INDUSTRY	32	Sep 28, 2026	clinicaltrials
NCT05482893	Spevatamig (PT886) as Monotherapy or in Combination With Chemo and/or Targeted Therapy and/or ICI, for the Treatment of Patients With Advanced Gastrointestinal Cancers, Including Gastric, Gastroesophageal Junction, Pancreatic Ductal or Biliary Tract Carcinomas (the TWINPEAK Study)	recruiting	Phase 1 / Phase 2	350	Phanes TherapeuticsINDUSTRY	1	Sep 28, 2026	clinicaltrials
NCT05646862	A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy(INAVO121)	recruiting	Phase 3	420	Hoffmann-La RocheINDUSTRY	20	Sep 28, 2026	clinicaltrials
NCT05867251	Study of AVZO-021 in Patients With Advanced Solid Tumors	recruiting	Phase 1 / Phase 2	430	Avenzo Therapeutics, Inc.INDUSTRY	2	Sep 28, 2026	clinicaltrials
NCT05981703	A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors	recruiting	Phase 1	337	BeOne MedicinesINDUSTRY	4	Sep 28, 2026	clinicaltrials
NCT06110793	A Study of Lenvatinib, Pembrolizumab, and Fulvestrant in People With Breast Cancer	active not recruiting	Phase 1 / Phase 2	56	Memorial Sloan Kettering Cancer CenterOTHER	1	Sep 28, 2026	clinicaltrials
NCT06120283	BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors	recruiting	Phase 1	433	BeOne MedicinesINDUSTRY	11	Sep 28, 2026	clinicaltrials
NCT06623422	A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)	recruiting	Phase 3	680	Merck Sharp & Dohme LLCINDUSTRY	31	Sep 28, 2026	clinicaltrials
NCT06787339	Capecitabine in Low Risk Triple Negative Breast Cancer(Calorite)	recruiting	Phase 2	198	Fudan UniversityOTHER	1	Sep 28, 2026	clinicaltrials
NCT06820463	A Study to Evaluate the Adverse Events, and Efficacy of Intravenous (IV) of Telisotuzumab Adizutecan in Combination With IV Oxaliplatin, Fluorouracil, Folinic Acid/Leucovorin, Bevacizumab, Panitumumab in Adult Participants With Metastatic Colorectal Cancer(AndroMETa-CRC)	recruiting	Phase 2	390	AbbVieINDUSTRY	15	Sep 28, 2026	clinicaltrials
NCT07190248	A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)	recruiting	Phase 3	675	Merck Sharp & Dohme LLCINDUSTRY	30	Sep 28, 2026	clinicaltrials
NCT07226349	A Study of BG-75098 Alone and in Combination With Other Agents in Adults With Advanced Solid Tumors	recruiting	Phase 1	105	BeOne MedicinesINDUSTRY	4	Sep 28, 2026	clinicaltrials
NCT07392892	Symbiotic-GI-16: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Gastroesophageal Cancer	recruiting	Phase 2 / Phase 3	840	PfizerINDUSTRY	10	Sep 28, 2026	clinicaltrials
NCT07525206	A Study to Access Intravenous (IV) Telisotuzumab Adizutecan in Combination With IV Bevacizumab Compared to Standard of Care IV Bevacizumabin Combination With Oral Trifluridine and Tipiracil in Adult Participants With Refractory Metastatic Colorectal Cancer(AndroMETa-CRC)	recruiting	Phase 3	990	AbbVieINDUSTRY	10	Sep 28, 2026	clinicaltrials
NCT07844551	ImmunoADC Therapy for Induction Conversion in Patients With Stage IVB OSCC/OPSCC	not yet recruiting	Phase 2	40	Huashan HospitalOTHER	0	Sep 28, 2026	clinicaltrials
NCT02595931	M6620 and Irinotecan Hydrochloride in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery	active not recruiting	Phase 1	66	National Cancer Institute (NCI)NIH	1	Sep 25, 2026	clinicaltrials
NCT02994069	Cisplatin + Radiation in SCCHN and Correlation With Oxidative Stress Markers	active not recruiting	Phase 2	80	Susanne ArnoldOTHER	1	Sep 25, 2026	clinicaltrials
NCT04253964	Pilot Study of Performance Status 2 vs. Performance Status 0-1 Non-small Cell Lung Cancer Patients Treated With Chemo/Immunotherapy	recruiting	Phase 2	105	Wake Forest University Health SciencesOTHER	1	Sep 25, 2026	clinicaltrials
NCT04267848	Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small Cell Lung Cancer, an ALCHEMIST Treatment Trial (Chemo-IO [ACCIO])	recruiting	Phase 3	1,210	National Cancer Institute (NCI)NIH	2	Sep 25, 2026	clinicaltrials
NCT05136196	BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study	recruiting	Phase 2	150	National Cancer Institute (NCI)NIH	1	Sep 25, 2026	clinicaltrials
NCT05647122	First in Human Study of AZD9592 in Solid Tumors(EGRET)	active not recruiting	Phase 1	190	AstraZenecaINDUSTRY	11	Sep 25, 2026	clinicaltrials
NCT06004245	A Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of VVD-133214 as Monotherapy and in Combination in Participants With Advanced Solid Tumors	recruiting	Phase 1	280	Vividion Therapeutics, Inc.INDUSTRY	11	Sep 25, 2026	clinicaltrials
NCT06312137	A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019)(TroFuse-019)	recruiting	Phase 3	780	Merck Sharp & Dohme LLCINDUSTRY	31	Sep 25, 2026	clinicaltrials
NCT06369259	Open-label Phase 2 Study of Avutometinib (RAF/MEK Clamp) in Combination With Defactinib (FAK Inhibitor) and Cetuximab in Patients With Unresectable, Anti-EGFR-Refractory Advanced Colorectal Cancer	recruiting	Phase 2	33	M.D. Anderson Cancer CenterOTHER	1	Sep 25, 2026	clinicaltrials
NCT06377852	The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study	recruiting	Phase 3	500	American Society of Clinical OncologyOTHER	1	Sep 25, 2026	clinicaltrials
NCT06428409	A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)	recruiting	Phase 1 / Phase 2	220	Merck Sharp & Dohme LLCINDUSTRY	13	Sep 25, 2026	clinicaltrials
NCT06979596	A Study of MK-5684 in People With Certain Solid Tumors (MK-5684-015/OMAHA-015)	recruiting	Phase 2	250	Merck Sharp & Dohme LLCINDUSTRY	13	Sep 25, 2026	clinicaltrials
NCT07007559	ASPEN-09-03: A Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Metastatic HER2-Positive Breast Cancer(ASPEN-09-03)	recruiting	Phase 2	120	ALX Oncology Inc.INDUSTRY	8	Sep 25, 2026	clinicaltrials
NCT07054190	A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer	recruiting	Phase 2	120	Hoffmann-La RocheINDUSTRY	7	Sep 25, 2026	clinicaltrials
NCT07216703	A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)	recruiting	Phase 3	1,023	Merck Sharp & Dohme LLCINDUSTRY	28	Sep 25, 2026	clinicaltrials
NCT07219212	A Study of JNJ-90301900 in Combination With Chemoradiation Therapy in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma(LUMIRAY)	recruiting	Phase 1	45	Johnson & Johnson Enterprise Innovation Inc.INDUSTRY	3	Sep 25, 2026	clinicaltrials
NCT07271355	Pressurized Intraperitoneal Aerosolized Chemotherapy With Mitomycin for the Treatment of Unresectable Appendix or Colorectal Cancer With Peritoneal Metastases, The IMPACT Trial	recruiting	Phase 3	129	City of Hope Medical CenterOTHER	1	Sep 25, 2026	clinicaltrials
NCT07276399	A Study of Amivantamab in Addition to Standard of Care Agents (SOC) Compared With SOC Alone in Participants With Recurrent/Metastatic Head and Neck Cancer(OrigAMI-5)	recruiting	Phase 3	500	Janssen Research & Development, LLCINDUSTRY	22	Sep 25, 2026	clinicaltrials
NCT07659795	A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Colorectal Cancer(TARGET-D 203)	recruiting	Phase 2	150	Verastem, Inc.INDUSTRY	2	Sep 25, 2026	clinicaltrials
NCT00295893	Combination Chemotherapy With or Without Trastuzumab in Treating Patients With Stage II or Stage III Breast Cancer	active not recruiting	Phase 2	121	City of Hope Medical CenterOTHER	1	Sep 24, 2026	clinicaltrials
NCT03573648	Neoadjuvant Endocrine Therapy, Palbociclib, Avelumab in Estrogen Receptor Positive Breast Cancer(ImmunoADAPT)	active not recruiting	Phase 2	33	Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsOTHER	1	Sep 24, 2026	clinicaltrials
NCT03716180	DAPHNe: Paclitaxel/Trastuzumab/Pertuzumab in HER2-Positive BC	active not recruiting	Phase 1	100	Dana-Farber Cancer InstituteOTHER	1	Sep 24, 2026	clinicaltrials
NCT05708235	A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population(MiRaDoR)	active not recruiting	Phase 2	976	MedSIROTHER	2	Sep 24, 2026	clinicaltrials
NCT05863195	Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone for Patients With Unresectable Colorectal Liver Metastases: The PUMP Trial	recruiting	Phase 3	408	ECOG-ACRIN Cancer Research GroupNETWORK	1	Sep 24, 2026	clinicaltrials
NCT06018337	A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02)	active not recruiting	Phase 3	541	DualityBio Inc.INDUSTRY	17	Sep 24, 2026	clinicaltrials
NCT06047379	Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis	recruiting	Phase 1 / Phase 2	134	Neonc Technologies, Inc.INDUSTRY	1	Sep 24, 2026	clinicaltrials
NCT07839819	Study of PM54 in Combination With Cytotoxic and Targeted Agents in Adult Participants With Advanced Malignancies	not yet recruiting	Phase 1 / Phase 2	231	PharmaMarINDUSTRY	4	Sep 24, 2026	clinicaltrials
NCT02194738	Genetic Testing in Screening Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial)	active not recruiting	N/A	7,458	National Cancer Institute (NCI)NIH	3	Sep 23, 2026	clinicaltrials
NCT03340506	Dabrafenib and/or Trametinib Rollover Study	recruiting	Phase 4	100	Novartis PharmaceuticalsINDUSTRY	14	Sep 23, 2026	clinicaltrials
NCT03899155	Pan Tumor Rollover Study	recruiting	Phase 2	1,500	Bristol-Myers SquibbINDUSTRY	38	Sep 23, 2026	clinicaltrials
NCT04400695	A Study of RC48-ADC for the Treatment of Locally Advanced or Metastatic Breast Cancer With Low Expression of HER2	recruiting	Phase 3	366	RemeGen Co., Ltd.INDUSTRY	1	Sep 23, 2026	clinicaltrials
NCT05061550	Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer(NeoCOAST-2)	recruiting	Phase 2	630	AstraZenecaINDUSTRY	12	Sep 23, 2026	clinicaltrials
NCT05489211	Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)	recruiting	Phase 2	454	AstraZenecaINDUSTRY	14	Sep 23, 2026	clinicaltrials
NCT06102902	Testing the Addition of Anti-cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment, Cetuximab Plus Encorafenib, for Colorectal Cancer	recruiting	Phase 1	30	National Cancer Institute (NCI)NIH	1	Sep 23, 2026	clinicaltrials
NCT06452277	A Study to Learn More About How Well Sevabertinib Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)(SOHO-02)	recruiting	Phase 3	555	BayerINDUSTRY	36	Sep 23, 2026	clinicaltrials

A study listed here tests a linked drug in a linked cancer; it does not necessarily select participants on this biomarker.

Bevacizumab

EU EMA

—

VEGZELMA in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. VEGZELMA in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1. VEGZELMA in combination with capecitabine is indicated for first line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with VEGZELMA in combination with capecitabine. For further information as to HER2 status, please refer to section 5.1. VEGZELMA, in addition to platinum based chemotherapy, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non small cell lung cancer (NSCLC) other than predominantly squamous cell histology. VEGZELMA, in combination with erlotinib, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent NSCLC with Epidermal Growth Factor Receptor (EGFR) activating mutations (see section 5.1). VEGZELMA, in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. VEGZELMA, in combination with carboplatin and paclitaxel is indicated for the front line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5.1). VEGZELMA, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vascular endothelial growth factor (VEGF) inhibitors or VEGF receptor–targeted agents. VEGZELMA in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents (see section 5.1). VEGZELMA, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.1).

approved

Aug 17, 2022

ema

Bevacizumab

EU EMA

—

Abevmy in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Abevmy in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1. Abevmy in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Abevmy in combination with capecitabine. For further information as to HER2 status, please refer to section 5.1. Abevmy, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. Abevmy, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations (see section 5.1). Abevmy in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. Abevmy, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics [FIGO] stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5.1). Abevmy, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents. Abevmy in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents (see section 5.1). Abevmy, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.1).

approved

Apr 21, 2021

ema

Bevacizumab

EU EMA

—

Oyavas in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Oyavas in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1. Oyavas in combination with capecitabine is indicated for first line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Oyavas in combination with capecitabine. For further information as to HER2 status, please refer to section 5.1. Oyavas, in addition to platinum based chemotherapy, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non small cell lung cancer other than predominantly squamous cell histology. Oyavas, in combination with erlotinib, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non squamous non small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations (see section 5.1). Oyavas in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. Oyavas, in combination with carboplatin and paclitaxel is indicated for the front line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5.1). Oyavas, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents. Oyavas, in combination with topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor targeted agents (see Section 5.1). Oyavas, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.1).

approved

Mar 26, 2021

ema

Bevacizumab

EU EMA

—

Alymsys in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Alymsys in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. Alymsys in combination with capecitabine is indicated for first line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Alymsys in combination with capecitabine. Alymsys, in addition to platinum based chemotherapy, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non small cell lung cancer other than predominantly squamous cell histology. Alymsys, in combination with erlotinib, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non squamous non small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations. Alymsys in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. Alymsys, in combination with carboplatin and paclitaxel is indicated for the front line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer. Alymsys, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor targeted agents. Alymsys, in combination with topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor targeted agents. Alymsys, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.

approved

Mar 26, 2021

ema

Bevacizumab

EU EMA

—

Onbevzi in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Onbevzi in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1. Onbevzi in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Onbevzi in combination with capecitabine. For further information as to HER2 status, please refer to section 5.1. Onbevzi, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. Onbevzi, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations. Onbevzi in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. Onbevzi, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer. Onbevzi, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor targeted agents. Onbevzi, in combination with topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor targeted agents. Onbevzi, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.

withdrawn

Jan 11, 2021

ema

Bevacizumab

EU EMA

—

Bevacizumab in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Bevacizumab in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1. Bevacizumab in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline- containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Equidacent in combination with capecitabine. For further information as to HER2 status, please refer to section 5.1. Bevacizumab, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. Bevacizumab, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations. Bevacizumab in combination with interferon alfa-2a is indicated for first-line treatment of adult patients with advanced and/or metastatic renal cell cancer. Bevacizumab, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages IIIB, IIIC and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5.1). Bevacizumab, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents. Bevacizumab, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.

withdrawn

Sep 24, 2020

ema

Bevacizumab

EU EMA

—

Aybintio in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Aybintio in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1 of the SmPC. Aybintio in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracyclinecontaining regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Aybintio in combination with capecitabine. For further information as to HER2 status, please refer to section 5.1 of the SmPC. Aybintio, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. Aybintio, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations (see section 5.1 of the SmPC). Aybintio in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. Aybintio, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5.1 of the SmPC). Aybintio, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor targeted agents. Aybintio, in combination with topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor targeted agents (see section 5.1 of the SmPC). Aybintio, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.1 of the SmPC).

approved

Aug 19, 2020

ema

Bevacizumab

EU EMA

—

Mvasi in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Mvasi in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1. Mvasi, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. Mvasi in combination with interferon alfa-2a is indicated for first-line treatment of adult patients with advanced and/or metastatic renal cell cancer. Mvasi, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages IIIB, IIIC and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer. Mvasi, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents. Mvasi in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents. Mvasi, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.

approved

Jan 15, 2018

ema

Bevacizumab

EU EMA

—

Bevacizumab in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Bevacizumab in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status. Bevacizumab in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline-containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Avastin in combination with capecitabine. For further information as to HER2 status. Bevacizumab, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. Bevacizumab, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations. Bevacizumab in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. Bevacizumab, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer.Bevacizumab, in combination with carboplatin and gemcitabine, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents. Bevacizumab in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents. Bevacizumab, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.

approved

Jan 12, 2005

ema

Approval rows flagged tumor-agnostic (2)

Associated cancers (18)

Drugs with predictive evidence (50)

Predictive evidence items (94)

Approvals mentioning the linked drugs (500)

Active trials (1,074)

Linked publications (56)