BRAF V600E — biomarker · CancerIndex

Biomarker · Gene alteration

BRAF V600E

BRAF codon 600 point mutation p.V600E detected by sequencing, PCR or mutation-specific immunohistochemistry; used as a predictive marker for BRAF/MEK inhibitor therapy across melanoma, thyroid, colorectal, lung and other cancers.

CI-BIO-00000018BRAF graph →NCIt C98342 Tumor-agnostic · 4 approval rows

Also calledp.V600E · BRAF V600E-mutant · c.1799T>A

Tissue-agnostic indications

Approval rows flagged tumor-agnostic (4)

Dabrafenib US FDA · Mar 16, 2023 · drug + indication textRegulatory approved
Dabrafenib US FDA · May 29, 2013 · drug + indication textRegulatory approved
Trametinib US FDA · Mar 16, 2023 · drug + indication textRegulatory approved
Trametinib US FDA · May 29, 2013 · drug + indication textRegulatory 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 (24)

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
Malignant Colorectal Neoplasm	37	31	6	—	1 / 21 / 6 / 8 / 1
Melanoma	31	29	2	—	0 / 19 / 2 / 10 / 0
Thyroid Gland Papillary Carcinoma	12	3	8

Derived

Drugs with predictive evidence (29)

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
VemurafenibSmall Molecule	45	36	9	A	34 / 9	Childhood Pilocytic Astrocytoma, Cholangiocarcinoma, Cutaneous Melanoma, Digestive System Neuroendocrine Tumor +12
DabrafenibSmall Molecule	22	19	3	A	18 / 4	Cholangiocarcinoma, Cutaneous Melanoma, Digestive System Neuroendocrine Tumor, Intrahepatic Cholangiocarcinoma +8
TrametinibSmall Molecule	20	19	1	A	18 / 0	Cholangiocarcinoma, Cutaneous Melanoma, Digestive System Neuroendocrine Tumor, Intrahepatic Cholangiocarcinoma +8
CetuximabMonoclonal Antibody	12	6	6	A	6 / 5	Malignant Colorectal Neoplasm
PanitumumabMonoclonal Antibody	9	6	3	B	4 / 2	Cholangiocarcinoma, Malignant Colorectal Neoplasm
IrinotecanSmall Molecule	6	3	3	B	3 / 3	Cholangiocarcinoma, Malignant Colorectal Neoplasm
SelumetinibSmall Molecule	4	3	1	B	1 / 1	Malignant Colorectal Neoplasm, Malignant Neoplasm, Melanoma
CobimetinibSmall Molecule	3	3	—	B	3 / 0	Malignant Colorectal Neoplasm, Malignant Neoplasm, Melanoma
EncorafenibSmall Molecule	3	3	—	A	3 / 0	Malignant Colorectal Neoplasm
BevacizumabMonoclonal Antibody	2	1	1	B	1 / 1	Malignant Colorectal Neoplasm
BinimetinibSmall Molecule	2	2	—	B	2 / 0	Malignant Colorectal Neoplasm
CapecitabineSmall Molecule	2	1	1	B	1 / 1	Malignant Colorectal Neoplasm
DactolisibSmall Molecule	2	2	—	D	2 / 0	Malignant Colorectal Neoplasm, Melanoma
OxaliplatinSmall Molecule	2	—	2	B	0 / 2	Malignant Colorectal Neoplasm
PLX4720	2	2	—	D	2 / 0	Malignant Colorectal Neoplasm, Melanoma
UprosertibSmall Molecule	2	2	—	D	2 / 0	Melanoma
ErlotinibSmall Molecule	1	1	—	D	1 / 0	Malignant Colorectal Neoplasm
FOLFOX-4 Regimen	1	—	1	B	0 / 1	Malignant Colorectal Neoplasm
GDC-0879Small Molecule	1	1	—	D	1 / 0	Malignant Colorectal Neoplasm
GefitinibSmall Molecule	1	1	—	D	1 / 0	Malignant Colorectal Neoplasm
JQEZ5	1	1	—	D	1 / 0	Melanoma
Nutlin-3Small Molecule	1	1	—	D	1 / 0	Melanoma
PertuzumabMonoclonal Antibody	1	1	—	C	1 / 0	Thyroid Gland Anaplastic Carcinoma
PictilisibSmall Molecule	1	1	—	C	1 / 0	Melanoma
Pictilisib Bismesylate	1	1	—	D	1 / 0	Malignant Colorectal Neoplasm
SorafenibSmall Molecule	1	1	—	D	1 / 0	Malignant Colorectal Neoplasm
TovorafenibSmall Molecule	1	1	—	A	1 / 0	Childhood Low Grade Glioma
MEK Inhibitor RO4987655	1	—	1	B	—	Melanoma
MirdametinibSmall Molecule	1	—	1	D	—	Melanoma

Curatedcivic items and knowledge edges as curated at the source.

Curated evidence

Predictive evidence items (92)

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 92 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
BRAF V600E + BRAF Fusion1
Tovorafenib	Childhood Low Grade Glioma	Predictive	A	Supports Sensitivity Response	5	accepted	EID12016 In this ongoing phase 2 trial (FIREFLY-1), 76 patients, aged 6 months to 25 years, with pediatric low-grade glioma harbouring BRAF alterations (BRAF fusions or BRAF V600E mutations) were treated with … (full text at CIViC) PMID 37978284 · Kilburn et al., 2024 · Open in CIViC	civic
BRAF V600E45
Vemurafenib	Childhood Pilocytic Astrocytoma	Predictive	C	Supports Sensitivity Response	3	accepted	EID3777 In a case report, a 28 month old patient with a cervicomedullary low grade glioma compatible with pilocytic astrocytoma which was resected had a second lesion consistent with a ganglioglioma 3 years l… (full text at CIViC) PMID 25524464 · del Bufalo et al., 2014 · Open in CIViC	civic
Dabrafenib + TrametinibCombination	Cholangiocarcinoma	Predictive	C	Supports Sensitivity Response	3	accepted	EID5902 Chemotherapy-refractory, metastatic cholangiocarcinoma with CNS involvement and a BRAF V600E mutation had a partial response at 8 weeks to dabrafenib and trametinib combination with complete radiologi… (full text at CIViC) PMID 28480077 · Kocsis et al., 2017 · Open in CIViC	civic
Irinotecan + Panitumumab + VemurafenibCombination	Cholangiocarcinoma
BRAF K601E + BRAF V600E1
Cobimetinib + VemurafenibCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	accepted	EID11670 This clinical study was conducted with 30 patients with colorectal cancer harboring BRAF V600E (n = 29) or BRAF K601E (n=1) mutations, treated with a combination of cobimetinib and vemurafenib. Of the… (full text at CIViC) PMID 36409971 · Klute et al., 2022 · Open in CIViC	civic
BRAF Amplification + BRAF V600E1
Selumetinib	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	E	Supports Resistance	4	accepted	EID92 COLO201 and COLO206F cells harboring BRAF V600E mutations were cloned to be MEK inhibitor (AZD6244 [selumetinib]) resistant. The mechanism of this resistance was shown to be amplification of the BRAF … (full text at CIViC) PMID 21098728 · Corcoran et al., 2010 · Open in CIViC	civic
ARAF S490T + BRAF V600EBRAF ARAF1
Cetuximab + Irinotecan + VemurafenibCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	C	Supports Resistance	1	accepted	EID1905 Phase 1b study of vemurafenib, cetuximab and irinotecan in 19 BRAF V600E mutant colorectal cancer patients. cfDNA panel sequencing was performed in 10 patients after disease progression. One patient h… (full text at CIViC) PMID 27729313 · Hong et al., 2016 · Open in CIViC	civic
BRAF V600E + GNAS R201CBRAF GNAS1
Cetuximab + Irinotecan + VemurafenibCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	C	Supports Resistance	2	accepted	EID1906 Phase 1b study of vemurafenib, cetuximab and irinotecan in 19 BRAF V600E mutant colorectal cancer patients. cfDNA panel sequencing was performed in 10 patients after disease progression. One patient a… (full text at CIViC) PMID 27729313 · Hong et al., 2016 · Open in CIViC	civic

Regulatory

Approvals mentioning the linked drugs (364)

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
Dabrafenib	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 (ORR) and duration of response (DoR). 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. • TAFINLAR is not indicated for treatment of patients with wild-type BRAF solid tumors. ( 5.2 )accelerated	approved	Mar 16, 2023	openfda
Dabrafenib	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 (ORR) and duration of response (DoR). 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. • TAFINLAR is not indicated for treatment of patients with wild-type BRAF solid tumors. ( 5.2 )accelerated	approved

1 record matched on indication text only (drug not in the derived set). Health Canada DIN rows carry no indication text and only match by drug.

Clinical trials

Active trials (473)

Trials with an active ClinicalTrials.gov status, an intervention mapped to a derived drug and a condition mapped to an associated cancer. 247 recruiting · 84 active phase 3 · 2,296 in any status. Most recently updated first, 50 per page.

Computedrule biomarker-links-v1

clinicaltrialsPublishedShowing 451–473 of 473 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
NCT05159245	The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs(FINPROVE)	recruiting	Phase 2	250	Helsinki University Central HospitalOTHER	1	Jul 15, 2024	clinicaltrials
NCT05462236	MNK Inhibitor AUM001 in Combination With Either Pembrolizumab or Irinotecan to Treat Metastatic Colorectal Cancer	recruiting	Phase 2	120	AUM Biosciences Pte LtdOTHER	1	Jul 9, 2024	clinicaltrials
NCT04143607	ASK120067 Versus Gefitinib as First-line Treatment for EGFRm Locally Advanced or Metastatic NSCLC	active not recruiting	Phase 3	337	Jiangsu Aosaikang Pharmaceutical Co., Ltd.INDUSTRY	1	Jun 14, 2024	clinicaltrials
NCT06446388	Study of QLS31905 and/or QL1706 Combination With Chemotherapy in the Advanced Malignant Solid Tumors	not yet recruiting	Phase 2	360	Qilu Pharmaceutical Co., Ltd.INDUSTRY	1	Jun 6, 2024	clinicaltrials
NCT06394713	A Study to Evaluate the Efficacy and Safety of QLF31907 Combination Therapy in Patients With Advanced Malignant Tumors	not yet recruiting	Phase 1 / Phase 2	60	Qilu Pharmaceutical Co., Ltd.INDUSTRY	0	May 1, 2024	clinicaltrials
NCT06373133	SHR-8068 Combined With Adbelizumab and BP102 in the Treatment of Advanced Colorectal Cancer	not yet recruiting	Phase 1 / Phase 2	36	West China HospitalOTHER	0	Apr 18, 2024	clinicaltrials
NCT06307249	Precision Therapy for Solid Tumors: Synergistic CDK4/6 Inhibition and Anti-VEGF Targeting LncRNA(PTST_PALBEVA)	recruiting	Phase 1	50	Lebanese UniversityOTHER	1	Mar 12, 2024	clinicaltrials
NCT05007132	Trifluridine/ Tipiracil Plus Panitumumab Versus Trifluridine/ Tipiracil Plus Bevacizumab as First-line Treatment of Metastatic Colorectal Cancer	recruiting	Phase 2	153	Dominik Paul ModestOTHER	1	Feb 15, 2024	clinicaltrials
NCT02925234	The Drug Rediscovery Protocol (DRUP Trial)(DRUP)	recruiting	Phase 2	1,550	The Netherlands Cancer InstituteOTHER	1	Jan 24, 2024	clinicaltrials
NCT06192680	Liposomal Irinotecan and Capecitabine Plus Bevacizumab as Second-line Therapy in Metastatic Colorectal Cancer	not yet recruiting	Phase 2	63	Harbin Medical UniversityOTHER	0	Jan 18, 2024	clinicaltrials
NCT06159478	Binimetinib in Patients With BRAF Fusion-positive Low-grade Glioma or Pancreatic Cancer (Perfume)(Perfume)	recruiting	Phase 2	32	National Cancer Center, JapanOTHER_GOV	1	Dec 13, 2023	clinicaltrials
NCT06067776	Osimertinib, Cetuximab, and Tucatinib for the Treatment of EGFR-Mutant Stage IV or Recurrent Non-small Lung Cell Cancer	not yet recruiting	Phase 1	36	Jonathan RiessOTHER	1	Oct 5, 2023	clinicaltrials
NCT06063070	First-line Maintenance Treatment With Fluzoparib Plus Bevacizumab in Advanced BRCA Wild Type Ovarian Cancer	not yet recruiting	Phase 2	44	Sun Yat-sen UniversityOTHER	1	Oct 2, 2023	clinicaltrials
NCT03563729	Melanoma Metastasized to the Brain and Steroids(MEMBRAINS)	recruiting	Phase 2	80	Inge Marie SvaneOTHER	1	Jul 13, 2023	clinicaltrials
NCT05354674	Multimodal Deep Learning Signature for Evaluation of Response to Bevacizumab in Patient With Colorectal Cancer Liver Metastasis	not yet recruiting	—	302	Fudan UniversityOTHER	1	Jul 13, 2023	clinicaltrials
NCT05797467	Adjuvant Chemotherapy Combined With Targeted Therapy or Not in the T3-4N2 Colorectal Cancer Patients	recruiting	Phase 3	366	Sixth Affiliated Hospital, Sun Yat-sen UniversityOTHER	1	May 24, 2023	clinicaltrials
NCT05797077	Postoperation Maintenance Therapy for Resectable Liver Metastases of Colorectal Cancer Guided by ctDNA	recruiting	Phase 3	346	Sixth Affiliated Hospital, Sun Yat-sen UniversityOTHER	1	Apr 4, 2023	clinicaltrials
NCT05725200	Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer(EVIDENT)	recruiting	Phase 2	40	Oslo University HospitalOTHER	1	Feb 21, 2023	clinicaltrials
NCT04304209	Pd1 Antibody Sintilimab ± Chemoradiotherapy for Locally Advanced Rectal Cancer	active not recruiting	Phase 2	195	Sun Yat-sen UniversityOTHER	1	Feb 1, 2023	clinicaltrials
NCT05699746	CAPEOX vs Observation in Colorectal Cancer Patients With Positive MRD	not yet recruiting	Phase 3	38	Zhejiang UniversityOTHER	1	Jan 26, 2023	clinicaltrials
NCT01638676	A Phase I/II Trial of Vemurafenib and Metformin to Melanoma Patients	recruiting	Phase 1 / Phase 2	55	University of LouisvilleOTHER	1	Oct 29, 2021	clinicaltrials
NCT04045691	Binimetinib Plus Encorafenib Real Life Investigation of Next Generation Melanoma Treatment(BERING)	recruiting	—	750	Pierre Fabre Pharma GmbHINDUSTRY	3	Jan 19, 2021	clinicaltrials
NCT02446431	Metronomic Therapy for Pediatric Patients With Solid Tumors at High Risk of Recurrence(Metronomic)	recruiting	Early Phase 1	20	Miller Children's & Women's Hospital Long BeachOTHER	1	May 18, 2015	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

—

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

—

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

—

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 (4)

Associated cancers (24)

Drugs with predictive evidence (29)

Predictive evidence items (92)

Approvals mentioning the linked drugs (364)

Active trials (473)

Linked publications (85)