KRAS mutation (any) — biomarker · CancerIndex

Biomarker · Gene alteration

KRAS mutation (any)

Activating KRAS mutations (codons 12, 13, 61 and others) detected by sequencing or PCR; used as a predictive marker, including as a negative predictor of response to anti-EGFR antibodies in colorectal cancer.

CI-BIO-00000016KRAS graph →NCIt C41361 Tumor-agnostic · 4 approval rows

Also calledKRAS-mutant · KRAS-mutated · RAS mutation

Tissue-agnostic indications

Approval rows flagged tumor-agnostic (4)

Dabrafenib US FDA · Mar 16, 2023 · drug in derived setRegulatory approved
Dabrafenib US FDA · May 29, 2013 · drug in derived setRegulatory approved
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 (26)

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	95	89	6	—	4 / 35 / 25 / 31 / 0
Lung Non-Small Cell Carcinoma	31	25	5	1	2 / 24 / 1 / 3 / 1
Multiple Myeloma	17	13	4

Derived

Drugs with predictive evidence (57)

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
CetuximabMonoclonal Antibody	47	6	41	A	5 / 39	Malignant Colorectal Neoplasm, Malignant Ovarian Neoplasm
PanitumumabMonoclonal Antibody	21	1	20	A	1 / 19	Colon Mucinous Adenocarcinoma, Malignant Colorectal Neoplasm
SelumetinibSmall Molecule	19	18	1	A	14 / 1	Lung Adenocarcinoma, Lung Non-Small Cell Carcinoma, Malignant Colorectal Neoplasm, Malignant Neoplasm
MelphalanSmall Molecule	13	—	13	B	0 / 13	Multiple Myeloma
ErlotinibSmall Molecule	11	3	8	B	1 / 7	Lung Adenocarcinoma, Lung Non-Small Cell Carcinoma, Malignant Colorectal Neoplasm, Malignant Pancreatic Neoplasm +1
Chemotherapy	10	—	10	B	0 / 9	Malignant Colorectal Neoplasm
GefitinibSmall Molecule	9	—	9	B	0 / 9	Lung Adenocarcinoma, Lung Non-Small Cell Carcinoma, Malignant Colorectal Neoplasm, Malignant Lung Neoplasm
Regorafenib AnhydrousSmall Molecule	9	1	8	B	0 / 7	Malignant Colorectal Neoplasm
DocetaxelSmall Molecule	8	7	1	A	5 / 1	Cutaneous Melanoma, Lung Non-Small Cell Carcinoma
TrametinibSmall Molecule	8	7	1	B	5 / 1	Lung Non-Small Cell Carcinoma, Malignant Colorectal Neoplasm, Malignant Neoplasm, Pancreatic Adenocarcinoma
DactolisibSmall Molecule	7	7	—	D	7 / 0	Lung Adenocarcinoma, Malignant Colorectal Neoplasm
VemurafenibSmall Molecule	5	1	4	B	0 / 4	Hairy Cell Leukemia, Malignant Colorectal Neoplasm, Melanoma
AfatinibSmall Molecule	4	4	—	C	4 / 0	Lung Non-Small Cell Carcinoma, Malignant Colorectal Neoplasm, Pancreatic Ductal Adenocarcinoma
IrinotecanSmall Molecule	4	1	3	B	1 / 2	Malignant Colorectal Neoplasm
Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor	3	2	1	B	2 / 1	Malignant Colorectal Neoplasm, Malignant Neoplasm
AbemaciclibSmall Molecule	2	2	—	B	2 / 0	Lung Non-Small Cell Carcinoma
AdagrasibSmall Molecule	2	2	—	A	2 / 0	Malignant Colorectal Neoplasm, Solid Neoplasm
BinimetinibSmall Molecule	2	2	—	B	2 / 0	Malignant Colorectal Neoplasm, Malignant Ovarian Serous Tumor
B-Raf/VEGFR-2 Inhibitor RAF265	2	2	—	D	2 / 0	Lung Non-Small Cell Carcinoma, Malignant Colorectal Neoplasm
CarboplatinSmall Molecule	2	1	1	B	1 / 1	Cutaneous Melanoma, Ovarian Carcinoma
DabrafenibSmall Molecule	2	—	2	B	0 / 2	Lung Adenocarcinoma, Melanoma
GemcitabineSmall Molecule	2	—	2	B	0 / 2	Malignant Pancreatic Neoplasm, Pancreatic Adenocarcinoma
PalbociclibSmall Molecule	2	2	—	D	2 / 0	Lung Non-Small Cell Carcinoma, Malignant Colorectal Neoplasm
SorafenibSmall Molecule	2	2	—	B	2 / 0	Cutaneous Melanoma, Hepatocellular Carcinoma
SotorasibSmall Molecule	2	2	—	A	2 / 0	Lung Non-Small Cell Carcinoma, Malignant Colorectal Neoplasm
TeprotumumabMonoclonal Antibody	2	2	—	B	2 / 0	Lung Non-Small Cell Carcinoma, Malignant Colorectal Neoplasm
BevacizumabMonoclonal Antibody	2	—	2	B	0 / 1	Malignant Colorectal Neoplasm
CrizotinibSmall Molecule	2	1	1	C	1 / 0	Malignant Colorectal Neoplasm, Malignant Neoplasm
RefametinibSmall Molecule	2	2	—	B	1 / 0	Hepatocellular Carcinoma, Malignant Colorectal Neoplasm
MEK Inhibitor RO4987655	2	1	1	B	—	Lung Non-Small Cell Carcinoma, Malignant Colorectal Neoplasm
Akt Inhibitor MK2206	1	1	—	C	1 / 0	Pancreatic Carcinoma
ARS-853	1	1	—	D	1 / 0	Malignant Neoplasm
AtezolizumabMonoclonal Antibody	1	1	—	B	1 / 0	Lung Non-Small Cell Carcinoma
AZD5438	1	1	—	D	1 / 0	Malignant Neoplasm
Cetuximab/Irinotecan Regimen	1	—	1	C	0 / 1	Malignant Colorectal Neoplasm
CisplatinSmall Molecule	1	—	1	B	0 / 1	Head and Neck Squamous Cell Carcinoma
DasatinibSmall Molecule	1	1	—	D	1 / 0	Malignant Colorectal Neoplasm
DecitabineSmall Molecule	1	1	—	D	1 / 0	Malignant Ovarian Neoplasm
DivarasibSmall Molecule	1	1	—	B	1 / 0	Lung Non-Small Cell Carcinoma
FOLFOX-4 Regimen	1	—	1	B	0 / 1	Malignant Colorectal Neoplasm
G-573	1	1	—	D	1 / 0	Malignant Neoplasm
Immune Checkpoint Inhibitor	1	1	—	E	1 / 0	Lung Non-Small Cell Carcinoma
Immunomodulatory Oligonucleotide	1	1	—	D	1 / 0	Malignant Colorectal Neoplasm
IxazomibSmall Molecule	1	—	1	D	0 / 1	Malignant Colorectal Neoplasm
MEK Inhibitor GDC-0623	1	1	—	D	1 / 0	Malignant Neoplasm
NivolumabMonoclonal Antibody	1	1	—	B	1 / 0	Lung Non-Small Cell Carcinoma
PaclitaxelSmall Molecule	1	—	1	B	0 / 1	Ovarian Carcinoma
PemetrexedSmall Molecule	1	1	—	B	1 / 0	Lung Non-Small Cell Carcinoma
PI3Kbeta Inhibitor AZD8186	1	1	—	D	1 / 0	Pancreatic Adenocarcinoma
PictilisibSmall Molecule	1	—	1	D	0 / 1	Malignant Breast Neoplasm
SCH772984Small Molecule	1	1	—	D	1 / 0	Pancreatic Adenocarcinoma
SirolimusSmall Molecule	1	1	—	D	1 / 0	Lung Adenocarcinoma
Therapeutic Tumor Infiltrating Lymphocytes	1	1	—	C	1 / 0	Malignant Colorectal Neoplasm
OxaliplatinSmall Molecule	1	—	1	B	—	Malignant Colorectal Neoplasm
RidaforolimusSmall Molecule	1	1	—	B	—	Malignant Endometrial Neoplasm
SalirasibSmall Molecule	1	1	—	B	—	Lung Adenocarcinoma
TemsirolimusSmall Molecule	1	1	—	B	—	Malignant Endometrial Neoplasm

Curatedcivic items and knowledge edges as curated at the source.

Curated evidence

Predictive evidence items (167)

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

civicCuratedShowing 101–150 of 167 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
KRAS G12V6
Panitumumab	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	C	Supports Resistance	—	accepted	EID2232 In a retrospective study of 427 metastatic colorectal patients, KRAS mutations were observed in 43% of the tumor samples. Patients with mutations in codon 12 or 13 of KRAS were associated with reduced… (full text at CIViC) PMID 18316791 · Amado et al., 2008 · Open in CIViC	civic
〃	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	C	Supports Resistance	3	accepted	EID3824 One patient participating in a large retrospective study of EGFR monoclonal antibodies in metastatic, treatment refractory colorectal cancer had a tumor which harbored KRAS G12V, was wildtype for NRAS… (full text at CIViC) PMID 20619739 · De Roock et al., 2010 · Open in CIViC	civic
Cetuximab + PanitumumabSubstitutes	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	C	Supports Resistance	2	accepted	EID6323 In this study, a large cohort of metastatic colorectal cancer patients were treated with anti-epidermal growth factor receptor monoclonal antibodies (cetuximab or panitumumab). KRAS, PIK3CA, and PTEN … (full text at CIViC) PMID 19223544 · Sartore-Bianchi et al., 2009 · Open in CIViC	civic
Regorafenib Anhydrous	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	D	Supports Resistance	2	accepted	EID3924 In an in vitro study, a human colon adenocarcinoma SW48 cell line expressing KRAS G12V mutation demonstrated resistance to regorafenib treatment (IC50: 241.90 nM vs. 114.28 nM, P<0.01) compared to SW4… (full text at CIViC) PMID 26161928 · Camaj et al., 2015 · Open in CIViC	civic
Gefitinib	Malignant Lung Neoplasm	Predictive	C	Supports Resistance	2	accepted	EID2268 In recurrent lung cancer patients treated with the epidermal growth factor receptor tyrosine kinase inhibitor gefitinib, patients with KRAS mutations had a lower frequency of partial response (PR) and… (full text at CIViC) PMID 17409929 · Endoh et al., 2006 · Open in CIViC	civic
Crizotinib	Malignant NeoplasmALIAS	Predictive	C	Does Not Support Resistance	2	accepted	EID1715 Case report of a 59-year-old white female patient (60 pack-years) with a CUP-syndrome. Molecular profiling identified both MET amplification (16 copies) and a KRAS G12V mutation. The patient was treat… (full text at CIViC) PMID 25232318 · Palma et al., 2014 · Open in CIViC	civic
KRAS G12D7
Panitumumab	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	C	Supports Resistance	—	accepted	EID2236 In a retrospective study of 427 metastatic colorectal patients, KRAS mutations were observed in 43% of the tumor samples. Patients with mutations in codon 12 or 13 of KRAS were associated with reduced… (full text at CIViC) PMID 18316791 · Amado et al., 2008 · Open in CIViC	civic
Cetuximab + PanitumumabSubstitutes	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	C	Supports Resistance	2	accepted	EID6316 In this study, a large cohort of metastatic colorectal cancer patients were treated with anti-epidermal growth factor receptor monoclonal antibodies (cetuximab or panitumumab). KRAS, PIK3CA, and PTEN … (full text at CIViC) PMID 19223544 · Sartore-Bianchi et al., 2009 · Open in CIViC	civic
Regorafenib Anhydrous
KRAS G12C5
Panitumumab	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	C	Supports Resistance	3	accepted	EID2253 In a retrospective study of 427 metastatic colorectal patients, KRAS mutations were observed in 43% of the tumor samples. Patients with mutations in codon 12 or 13 of KRAS were associated with reduced… (full text at CIViC) PMID 18316791 · Amado et al., 2008 · Open in CIViC	civic
Regorafenib Anhydrous	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	D	Supports Resistance	2	accepted	EID3973 In an in vitro study, a human colon adenocarcinoma SW48 cell line expressing KRAS G12C mutation demonstrated resistance to regorafenib treatment (IC50: 386.22 nM vs. 114.28 nM, P<0.01) compared to SW4… (full text at CIViC) PMID 26161928 · Camaj et al., 2015 · Open in CIViC	civic
Panitumumab + SotorasibCombination
KRAS G12R2
Panitumumab	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	C	Supports Resistance	—	accepted	EID2264 In a retrospective study of 427 metastatic colorectal patients, KRAS mutations were observed in 43% of the tumor samples. Patients with mutations in codon 12 or 13 of KRAS were associated with reduced… (full text at CIViC) PMID 18316791 · Amado et al., 2008 · Open in CIViC	civic
Regorafenib Anhydrous	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	D	Supports Resistance	1	accepted	EID3991 In an in vitro study, a human colon adenocarcinoma SW48 cell line expressing KRAS G12R mutation demonstrated resistance to regorafenib treatment (IC50: 181.77 nM vs. 114.28 nM, P<0.01) compared to SW4… (full text at CIViC) PMID 26161928 · Camaj et al., 2015 · Open in CIViC	civic
KRAS G12S3
Panitumumab	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	C	Supports Resistance	—	accepted	EID2269 In a retrospective study of 427 metastatic colorectal patients, KRAS mutations were observed in 43% of the tumor samples. Patients with mutations in codon 12 or 13 of KRAS were associated with reduced… (full text at CIViC) PMID 18316791 · Amado et al., 2008 · Open in CIViC	civic
Regorafenib Anhydrous	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	D	Supports Resistance	2	accepted	EID4012 In an in vitro study, a human colon adenocarcinoma SW48 cell line expressing KRAS G12S mutation demonstrated resistance to regorafenib treatment (IC50: 264.23 nM vs. 114.28 nM, P<0.01) compared to SW4… (full text at CIViC) PMID 26161928 · Camaj et al., 2015 · Open in CIViC	civic
Gefitinib	Malignant Lung Neoplasm
KRAS G13D2
Cetuximab + PanitumumabSubstitutes	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	C	Supports Resistance	2	accepted	EID6322 In this study, a large cohort of metastatic colorectal cancer patients were treated with anti-epidermal growth factor receptor monoclonal antibodies (cetuximab or panitumumab). KRAS G13D was the only … (full text at CIViC) PMID 19223544 · Sartore-Bianchi et al., 2009 · Open in CIViC	civic
Regorafenib Anhydrous	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	D	Supports Resistance	1	accepted	EID3889 In an in vitro study, a human colon adenocarcinoma SW48 cell line expressing KRAS G13D mutation demonstrated resistance to regorafenib treatment (IC50: 172.23 nM vs. 114.28 nM, P<0.01) compared to SW4… (full text at CIViC) PMID 26161928 · Camaj et al., 2015 · Open in CIViC	civic
KRAS Mutation + MET AmplificationMET KRAS1
Cetuximab/Irinotecan Regimen + PanitumumabSubstitutes	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	C	Supports Resistance	3	accepted	EID1971 7 patients with acquired resistance to EGFR inhibitors were analyzed in this study. Of these, 4 did not develop KRAS mutations. Post- and Pre-Treatment tissued was available of three patients and MET … (full text at CIViC) PMID 23729478 · Bardelli et al., 2013 · Open in CIViC	civic
KRAS Mutation9
Refametinib	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	C	Does Not Support Sensitivity Response	2	accepted	EID1001 Phase I trial of the mitogen-activated protein kinase 1/2 inhibitor BAY 86-9766. 4 patients with KRAS +/- PIK3CA mutant colorectal cancer. 3 with SD, 1 with PD. PMID 23434733 · Weekes et al., 2013 · Open in CIViC	civic
Selumetinib + TeprotumumabCombination	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	D	Supports Sensitivity Response	3	accepted	EID1004 Preclinial data from KRAS mutant colorectal cancer cell lines show syngergistic effect on cell viability and apoptosis in vitro and in vivo when MEK and IGF-IR are inhibited concomitantly. In other ce… (full text at CIViC) PMID 21985784 · Ebi et al., 2011 · Open in CIViC	civic
Afatinib + Trametinib
KRAS Exon 2 Mutation3
Regorafenib Anhydrous	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Does Not Support Sensitivity Response	1	accepted	EID87 KRAS mutation status was not predictive of response to regorafenib treatment in patients that had received standard therapy and progressed within 3 months of their last treatment. KRAS exon 2 variants… (full text at CIViC) PMID 24559322 · Sartore-Bianchi et al., 2014 · Open in CIViC	civic
Vemurafenib	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	D	Does Not Support Sensitivity Response	3	accepted	EID8367 This preclinical study examined vemurafenib efficacy on various colorectal cancer cell lines and in vivo via mouse xenograft experiments. Three cell lines harbored KRAS exon 2 mutations and wt BRAF: H… (full text at CIViC) PMID 22180495 · Yang et al., 2012 · Open in CIViC	civic
Erlotinib + Gemcitabine
KRAS G12A6
Regorafenib Anhydrous	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	D	Supports Resistance	2	accepted	EID3710 In an in vitro study, a human colon adenocarcinoma SW48 cell line virally transduced to express KRAS G12A demonstrated resistance to regorafenib treatment (IC50: 330.13 nM vs. 114.28 nM, P<0.01, repor… (full text at CIViC) PMID 26161928 · Camaj et al., 2015 · Open in CIViC	civic
Gefitinib	Malignant Lung Neoplasm	Predictive	B	Supports Resistance	2	accepted	EID2008 In recurrent lung cancer patients treated with the epidermal growth factor receptor tyrosine kinase inhibitor gefitinib, patients with KRAS mutations had a lower frequency of partial response (PR) and… (full text at CIViC) PMID 17409929 · Endoh et al., 2006 · Open in CIViC	civic
Melphalan	Multiple Myeloma	Predictive	B
KRAS Wildtype1
Regorafenib Anhydrous	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	D	Does Not Support Resistance	2	accepted	EID8840 In an in vitro study, a human colon adenocarcinoma SW48 cell line expressing KRAS wildtype did not demonstrate resistance to regorafenib treatment (IC50: 114.28 nM) compared to SW48 cells expressing v… (full text at CIViC) PMID 26161928 · Camaj et al., 2015 · Open in CIViC	civic
BRAF V600E + HRAS Mutation + KRAS Mutation + NF1 Mutation + NRAS MutationHRAS BRAF NF1 KRAS NRAS1
Selumetinib	Malignant NeoplasmALIAS	Predictive	B	Does Not Support Sensitivity Response	3	accepted	EID11681 In this phase II study of the arm E of the NCI-COG pediatric MATCH trial, 20 patients (median age: 14) were treated with Selumetinib. High-grade glioma (n=7) and rhabdomyosarcoma (n=7) were the most c… (full text at CIViC) PMID 35363510 · Eckstein et al., 2022 · Open in CIViC	civic
BRAF V600E + HRAS Mutation + KRAS Mutation + NF1 Inactivating Mutation + NRAS MutationHRAS NF1 BRAF KRAS NRAS1
Selumetinib	Malignant NeoplasmALIAS	Predictive	B	Does Not Support Sensitivity Response	3	accepted	EID11696 In this Phase II study, 20 patients harboring activating RAS gene mutations (KRAS = 8, NRAS = 3. HRAS = 1), BRAF V600E mutations, and NF1 inactivating mutations (n=7) were treated with Selumetinib. No… (full text at CIViC) PMID 35363510 · Eckstein et al., 2022 · Open in CIViC	civic
BRAF V600E + KRAS G12DBRAF KRAS1
Vemurafenib	Melanoma	Predictive	D	Supports Resistance	2	accepted	EID3957 In vitro studies of M229 (a human melanoma cell line) endogenously expressing wildtype KRAS and BRAF V600E (a known BRAF inhibitor sensitizing mutation) found that cells virally induced to stably over… (full text at CIViC) PMID 24265155 · Shi et al., 2014 · Open in CIViC	civic
KRAS Amplification1
Vemurafenib	Melanoma	Predictive	D	Supports Resistance	2	accepted	EID6317 In vitro studies of M229 (a human melanoma cell line) endogenously expressing wildtype KRAS and BRAF V600E (a known BRAF sensitizing mutation) found that cells induced to stably over-express wildtype … (full text at CIViC) PMID 24265155 · Shi et al., 2014 · Open in CIViC	civic
BRAF V600E + KRAS MutationBRAF KRAS1
Dabrafenib + VemurafenibSubstitutes	Melanoma	Predictive	B	Supports Resistance	2	accepted	EID6264 In a retrospective study of 44 relapsed melanoma patients harboring BRAF V600E or V600K (known BRAF inhibitor sensitizing mutations), MAPK pathway reactivation mechanisms were implicated in acquired r… (full text at CIViC) PMID 24265155 · Shi et al., 2014 · 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

health-canada-dpdRegulatory50 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
Docetaxel	CA Health Canada	—	Marketed in Canada as PMS-DOCETAXEL (DIN 02436388) under ATC L01CD02 DOCETAXEL. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Mar 15, 2023	—	health-canada-dpd
Docetaxel	CA Health Canada	—	Marketed in Canada as ACT DOCETAXEL 40 MG/ML (DIN 02444410) under ATC L01CD02 DOCETAXEL. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Jul 24, 2020	—	health-canada-dpd
Docetaxel	CA Health Canada	—	Marketed in Canada as PMS-DOCETAXEL (DIN 02436361) under ATC L01CD02 DOCETAXEL. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

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

Clinical trials

Active trials (1,651)

Trials with an active ClinicalTrials.gov status, an intervention mapped to a derived drug and a condition mapped to an associated cancer. 795 recruiting · 365 active phase 3 · 7,948 in any status. Most recently updated first, 50 per page.

Computedrule biomarker-links-v1

clinicaltrialsPublishedShowing 751–800 of 1,651 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
NCT04658147	Feasibility and Efficacy of Perioperative Nivolumab With or Without Relatlimab for Patients With Potentially Resectable Hepatocellular Carcinoma (HCC)	active not recruiting	Phase 1	31	Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsOTHER	1	Jun 11, 2026	clinicaltrials
NCT04728230	Olaparib and Durvalumab With Carboplatin, Etoposide, and/or Radiation Therapy for the Treatment of Extensive-Stage Small Cell Lung Cancer, PRIO Trial	active not recruiting	Phase 1 / Phase 2	63	M.D. Anderson Cancer CenterOTHER	1	Jun 11, 2026	clinicaltrials
NCT05076760	MEM-288 Oncolytic Virus Alone and in Combination With Standard of Care Therapy in Advanced Solid Tumors	recruiting	Phase 1	40	Memgen, Inc.INDUSTRY	1	Jun 11, 2026	clinicaltrials
NCT07318389	ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer	not yet recruiting	Early Phase 1	100	M.D. Anderson Cancer CenterOTHER	1	Jun 11, 2026	clinicaltrials
NCT03017820	A Vaccine (VSV-hIFNβ-NIS) With or Without Cyclophosphamide and Combinations of Ipilimumab, Nivolumab, and Cemiplimab in Treating Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia or Lymphoma	recruiting	Phase 1	99	Mayo ClinicOTHER	1	Jun 10, 2026	clinicaltrials
NCT04332367	Carboplatin, Taxane And Ramucirumab for Patients With NSCLC After Pemetrexed or Pembrolizumab Maintenance	recruiting	Phase 2	59	Abramson Cancer Center at Penn MedicineOTHER	1	Jun 10, 2026	clinicaltrials
NCT04587128	Early-Line Anti-EGFR Therapy to Facilitate Retreatment for Select Patients With mCRC	active not recruiting	Phase 2	34	University of Wisconsin, MadisonOTHER	1	Jun 10, 2026	clinicaltrials
NCT05317000	5-Azacytidine and/or Nivolumab in Resectable HPV-Associated HNSCC	recruiting	Phase 2	50	Barbara BurtnessOTHER	1	Jun 10, 2026	clinicaltrials
NCT05655312	MC1R-targeted Alpha-particle Monotherapy and Combination Therapy Trial With Nivolumab in Adults With Advanced Melanoma	recruiting	Phase 1 / Phase 2	300	Perspective TherapeuticsINDUSTRY	1	Jun 10, 2026	clinicaltrials
NCT05827055	Proglumide and Chemotherapy for Metastatic Pancreatic Cancer(ProGem)	active not recruiting	Phase 2	30	Georgetown UniversityOTHER	1	Jun 10, 2026	clinicaltrials
NCT06107868	Phase 1 Study of RP-6306 With Carboplatin and Paclitaxel in TP53 Ovarian and Uterine Cancer(GyneRep)	active not recruiting	Phase 1	6	University Health Network, TorontoOTHER	1	Jun 10, 2026	clinicaltrials
NCT06835569	A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations	recruiting	Phase 1	448	Alterome Therapeutics, Inc.INDUSTRY	1	Jun 10, 2026	clinicaltrials
NCT06986785	A Study of BL-B01D1 Monotherapy, BL-B01D1 in Combination With Lenvatinib, BL-B01D1 in Combination With PD-1 Monoclonal Antibody, and BL-B01D1 in Combination With PD-1 Monoclonal Antibody and Bevacizumab in Patients With Advanced Hepatocellular Carcinoma	recruiting	Phase 2	74	Sichuan Baili Pharmaceutical Co., Ltd.INDUSTRY	1	Jun 10, 2026	clinicaltrials
NCT06265285	Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program	recruiting	Phase 2	50	Mayo ClinicOTHER	1	Jun 9, 2026	clinicaltrials
NCT07226856	BMS-986340 in Combination With Nivolumab, Gemcitabine and Nab-paclitaxel for the Treatment of Metastatic and Recurrent Pancreatic Adenocarcinoma	recruiting	Phase 2	43	Mayo ClinicOTHER	1	Jun 9, 2026	clinicaltrials
NCT01993810	Comparing Photon Therapy To Proton Therapy To Treat Patients With Lung Cancer	active not recruiting	Phase 3	330	Radiation Therapy Oncology GroupNETWORK	1	Jun 8, 2026	clinicaltrials
NCT03137771	Maintenance Chemotherapy With or Without Local Consolidative Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer	active not recruiting	Phase 2	218	NRG OncologyOTHER	4	Jun 8, 2026	clinicaltrials
NCT03839342	Binimetinib and Encorafenib for the Treatment of Advanced Solid Tumors With Non-V600E BRAF Mutations(BEAVER)	active not recruiting	Phase 2	26	University Health Network, TorontoOTHER	1	Jun 8, 2026	clinicaltrials
NCT03939481	Treatment Effects on Development of Chemotherapy-Induced Peripheral Neuropathy in Patients With Cancer	active not recruiting	—	1,336	SWOG Cancer Research NetworkNETWORK	4	Jun 8, 2026	clinicaltrials
NCT03947385	Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions	recruiting	Phase 1 / Phase 2	336	IDEAYA BiosciencesINDUSTRY	3	Jun 8, 2026	clinicaltrials
NCT05819892	Phase I Trial Testing the Safety and Tolerability of Chemoradiation Followed by Chemotherapy + Dostarlimab for Stage IIIC, Node Positive, Endometrial Cancer	recruiting	Phase 1	21	M.D. Anderson Cancer CenterOTHER	1	Jun 8, 2026	clinicaltrials
NCT06026410	KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors(FIT-001)	recruiting	Phase 1	300	Kura Oncology, Inc.INDUSTRY	5	Jun 8, 2026	clinicaltrials
NCT06377111	A Study to Test the Benefit of Vitamin B5 in Patients With Melanoma	active not recruiting	Phase 1	12	University Health Network, TorontoOTHER	1	Jun 8, 2026	clinicaltrials
NCT07634094	Intensive Locoregional Chemoimmunotherapy, Intradermal Autologous Alpha-DC1 Vaccines, and Systemic Pembrolizumab for Advanced-Stage Ovarian Cancer	not yet recruiting	Phase 2	28	Kalinski, Pawel, MD, PhDOTHER	1	Jun 8, 2026	clinicaltrials
NCT02738866	Palbociclib With Fulvestrant for Metastatic Breast Cancer After Treatment With Palbociclib and an Aromatase Inhibitor	active not recruiting	Phase 2	60	Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsOTHER	1	Jun 5, 2026	clinicaltrials
NCT04074096	Binimetinib Encorafenib Pembrolizumab +/- Stereotactic Radiosurgery in BRAFV600 Melanoma With Brain Metastasis(BEPCOME-MB)	active not recruiting	Phase 2	10	UNICANCEROTHER	1	Jun 5, 2026	clinicaltrials
NCT07628894	Circadian-Optimized Light Therapy for the Treatment of Patients With Advanced Melanoma Receiving Tumor-Infiltrating Lymphocyte Therapy	not yet recruiting	Phase 1	8	City of Hope Medical CenterOTHER	1	Jun 5, 2026	clinicaltrials
NCT06319196	Clear Me: Interception Trial to Detect and Clear Molecular Residual Disease in Patients With High-risk Melanoma(ClearMe)	recruiting	Phase 2	54	University Health Network, TorontoOTHER	1	Jun 4, 2026	clinicaltrials
NCT06463665	Efficacy & Safety of Olvimulogene Nanivacirepvec & Platinum-doublet + Physician's Choice of Immune Checkpoint Inhibitor Compared to Docetaxel in NSCL Cancer(VIRO-25)	recruiting	Phase 2	142	Genelux CorporationINDUSTRY	1	Jun 4, 2026	clinicaltrials
NCT06856213	Study of Cetuximab Plus/Minus Weekly Paclitaxel After Progression To First-Line Pembrolizumab Plus Platinum-5FU in Subjects With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck.(ERBIOTAX)	recruiting	Phase 2	65	Grupo Español de Tratamiento de Tumores de Cabeza y CuelloOTHER	1	Jun 4, 2026	clinicaltrials
NCT07234877	Phase II Study of Upfront SRT Plus Ivonescimab/Chemotherapy vs Ivonescimab/Chemotherapy in NSCLC Brain Mets	not yet recruiting	Phase 2	158	European Organisation for Research and Treatment of Cancer - EORTCNETWORK	8	Jun 4, 2026	clinicaltrials
NCT07581704	Sirolimus Pre-conditioning on T Cell Activity and T-cell Engaging Bispecific Antibody Efficacy in Multiple Myeloma	recruiting	Phase 1	10	Christopher StrouseOTHER	1	Jun 4, 2026	clinicaltrials
NCT00492999	Hepatic Arterial Infusion With Floxuridine and Dexamethasone Combined With Combination Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver	active not recruiting	Phase 2	64	Memorial Sloan Kettering Cancer CenterOTHER	1	Jun 3, 2026	clinicaltrials
NCT04753879	Multi-agent Low Dose Chemotherapy GAX-CI Followed by Olaparib and Pembro in Metastatic Pancreatic Ductal Cancer.	active not recruiting	Phase 2	38	Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsOTHER	1	Jun 3, 2026	clinicaltrials
NCT07076121	A Study Comparing Navlimetostat (BMS-986504) in Combination With Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine in Participants With Untreated Metastatic Pancreatic Ductal Adenocarcinoma With Homozygous MTAP Deletion (MountainTAP-30)	active not recruiting	Phase 2 / Phase 3	470	Bristol-Myers SquibbINDUSTRY	36	Jun 3, 2026	clinicaltrials
NCT04796012	VITAS: Atezolizumab in Combination With Chemotherapy for Pediatric Relapsed/Refractory Solid Tumors	recruiting	Phase 1 / Phase 2	23	University of Texas Southwestern Medical CenterOTHER	1	Jun 2, 2026	clinicaltrials
NCT05445778	Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer(GLORIOSA)	active not recruiting	Phase 3	520	AbbVieINDUSTRY	22	Jun 2, 2026	clinicaltrials
NCT06625320	Phase 3 Study of Daraxonrasib (RMC-6236) in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)(RASolute 302)	active not recruiting	Phase 3	500	Revolution Medicines, Inc.INDUSTRY	7	Jun 2, 2026	clinicaltrials
NCT06917079	BBO-11818 in Adult Subjects With KRAS Mutant Cancer	recruiting	Phase 1	665	TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)INDUSTRY	2	Jun 2, 2026	clinicaltrials
NCT07621497	FOLFOX8 Versus mFOLFOX6 With Bevacizumab or Cetuximab for First-Line Unresectable Metastatic Colorectal Cancer (Phase II)	not yet recruiting	Phase 2	229	Sun Yat-sen UniversityOTHER	1	Jun 2, 2026	clinicaltrials
NCT02451982	Platform Study of Neoadjuvant and Adjuvant Immunotherapy for Patients With Resectable Adenocarcinoma of the Pancreas	active not recruiting	Phase 2	76	Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsOTHER	1	Jun 1, 2026	clinicaltrials
NCT03935893	Adoptive Transfer of Tumor Infiltrating Lymphocytes for Advanced Solid Cancers	active not recruiting	Phase 2	20	Udai KammulaOTHER	1	Jun 1, 2026	clinicaltrials
NCT05039801	IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors	recruiting	Phase 1	54	M.D. Anderson Cancer CenterOTHER	1	Jun 1, 2026	clinicaltrials
NCT05633667	Study of Novel Treatment Combinations in Patients With Lung Cancer(VELOCITY-Lung)	active not recruiting	Phase 2	192	Gilead SciencesINDUSTRY	8	Jun 1, 2026	clinicaltrials
NCT05676931	Study With Various Immunotherapy Treatments in Participants With Lung Cancer(EDGE-Lung)	active not recruiting	Phase 2	400	Gilead SciencesINDUSTRY	10	Jun 1, 2026	clinicaltrials
NCT07618624	BRIDGE Study: Neoadjuvant Finotonlimab, Cetuximab, and Docetaxel in Resectable Recurrent HNSCC After Immunotherapy Progression(BRIDGE)	enrolling by invitation	Phase 2	42	Sun Yat-sen UniversityOTHER	1	Jun 1, 2026	clinicaltrials
NCT04956640	Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)	active not recruiting	Phase 1 / Phase 2	540	Eli Lilly and CompanyINDUSTRY	6	May 29, 2026	clinicaltrials
NCT04514484	Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV	active not recruiting	Phase 1	8	National Cancer Institute (NCI)NIH	1	May 28, 2026	clinicaltrials
NCT05582499	Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy(FASCINATE-N)	recruiting	Phase 2	716	Fudan UniversityOTHER	1	May 28, 2026	clinicaltrials
NCT06246110	A Phase 2 Study of EIK1001 in Combo With Pembrolizumab and Chemotherapy in Patients With Stage 4 NSCLC	active not recruiting	Phase 2	70	Eikon TherapeuticsINDUSTRY	1	May 28, 2026	clinicaltrials

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

Docetaxel

EU EMA

—

Breast cancer Taxespira in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. Taxespira in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Taxespira monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Taxespira combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express HER2 and who previously have not received chemotherapy for metastatic disease. Taxespira in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small cell lung cancer Taxespira indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy. Taxespira in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer, in patients who have not previously received chemotherapy for this condition. Prostate cancer Taxespira in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer. Gastric adenocarcinoma Taxespira in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer Taxespira in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

withdrawnsince Oct 30, 2018

Aug 28, 2015

ema

Docetaxel

EU EMA

—

Breast cancer Docetaxel Accord in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. Docetaxel Accord in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Docetaxel Accord monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Docetaxel Accord in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease. Docetaxel Accord in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small-cell lung cancer Docetaxel Accord is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy. Docetaxel Accord in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition. Prostate cancer Docetaxel Accord in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer. Gastric adenocarcinoma Docetaxel Accord in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer Docetaxel Accord in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

approved

May 22, 2012

ema

Docetaxel

EU EMA

—

Breast cancer Docetaxel Kabi in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. Docetaxel Kabi in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Docetaxel Kabi monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Docetaxel Kabi in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease. Docetaxel Kabi in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small-cell lung cancer Docetaxel Kabi is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy. Docetaxel Kabi in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition. Prostate cancer Docetaxel Kabi in combination with prednisone or prednisolone is indicated for the treatment of patients with castration-resistant metastatic prostate cancer. Docetaxel Kabi in combination with androgen-deprivation therapy (ADT), with or without prednisone or prednisolone, is indicated for the treatment of patients with metastatic hormone-sensitive prostate cancer. Gastric adenocarcinoma Docetaxel Kabi in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer Docetaxel Kabi in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

approved

May 22, 2012

ema

Docetaxel

EU EMA

—

Breast cancer Docetaxel in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer. Docetaxel in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Docetaxel monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Docetaxel in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express HER2 and who previously have not received chemotherapy for metastatic disease. Docetaxel in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small cell lung cancer Docetaxel is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy. Docetaxel in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer, in patients who have not previously received chemotherapy for this condition. Prostate cancer Docetaxel in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer. Gastric adenocarcinoma Docetaxel in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer Docetaxel in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

withdrawnsince May 25, 2012

May 10, 2010

ema

Docetaxel

EU EMA

—

Breast cancer Docetaxel Teva in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. Docetaxel Teva in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Docetaxel Teva monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Docetaxel Teva in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease. Docetaxel Teva in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small-cell lung cancer Docetaxel Teva is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy. Docetaxel Teva in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition. Prostate cancer Docetaxel Teva in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer. Gastric adenocarcinoma Docetaxel Teva in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer Docetaxel Teva in combination with cisplatin and 5 fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

withdrawn

Jan 26, 2010

ema

Docetaxel

EU EMA

—

Breast cancer Docetaxel Winthrop in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. Docetaxel Winthrop in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Docetaxel Winthrop monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Docetaxel Winthrop in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease. Docetaxel Winthrop in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small-cell lung cancer Docetaxel Winthrop is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy. Docetaxel Winthrop in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition. Prostate cancer Docetaxel Winthrop in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone-refractory metastatic prostate cancer. Gastric adenocarcinoma Docetaxel Winthrop in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer Docetaxel Winthrop in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

withdrawn

Apr 20, 2007

ema

Docetaxel

EU EMA

—

Breast cancer Taxotere in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: operable node-positive breast cancer; operable node-negative breast cancer. For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. Taxotere in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Taxotere monotherapy is indicated for the treatment of patients with locally advanced ormetastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Taxotere in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease. Taxotere in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Non-small-cell lung cancer Taxotere is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy. Taxotere in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition. Prostate cancer Taxotere in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer. Gastric adenocarcinoma Taxotere in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and neck cancer Taxotere in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

approved

Nov 27, 1995

ema

Approval rows flagged tumor-agnostic (4)

Associated cancers (26)

Drugs with predictive evidence (57)

Predictive evidence items (167)

Approvals mentioning the linked drugs (500)

Active trials (1,651)

Linked publications (113)