BRCA1 mutation

Clinical trials

Active trials (499)

Trials with an active ClinicalTrials.gov status, an intervention mapped to a derived drug and a condition mapped to an associated cancer. 238 recruiting · 93 active phase 3 · 2,184 in any status. Most recently updated first, 50 per page.

Computedrule biomarker-links-v1

clinicaltrialsPublishedShowing 1–50 of 499 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
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)

Literature

Linked publications (34)

Publications linked to the scope gene(s) through PubMed entity edges; 25 per page, newest first.

pubmedPublishedShowing 1–25 of 34 publications · bibliographic data as recorded by PubMed; abstracts are not reproduced.

Maintenance Olaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer.
· N Engl J Med · 2018 · PMID 30345884 · validated civic_curation pubmed
Maintenance Olaparib for Germline BRCA-Mutated Metastatic Pancreatic Cancer.
· N Engl J Med · 2019 · PMID 31157963 · validated civic_curation pubmed
Olaparib for Metastatic Castration-Resistant Prostate Cancer.
· N Engl J Med · 2020 · PMID 32343890 · validated civic_curation pubmed
Antitumor activity and safety of the PARP inhibitor rucaparib in patients with high-grade ovarian carcinoma and a germline or somatic BRCA1 or BRCA2 mutation: Integrated analysis of data from Study 10 and ARIEL2.
· Gynecol Oncol · 2017 · PMID 28882436 · validated

BRCA1 Mutation19
Olaparib	Castration-Resistant Prostate Carcinoma	Predictive	A	Supports Sensitivity Response	4	accepted	EID11203 This randomized, open-label, phase 3 trial evaluated the PARP inhibitor olaparib in 387 men with metastatic castration-resistant prostate cancer (mCRPC) who had disease progression while receiving a n… (full text at CIViC) PMID 32343890 · de Bono et al., 2020 · Open in CIViC	civic
〃	Malignant NeoplasmALIAS	Predictive	B	Supports Sensitivity Response	4	accepted	EID1370 In this phase 1 trial, 60 patients with advanced solid tumors (ovarian, breast, colorectal, melanoma, sarcoma, prostate) were treated with PARP inhibitor olaparib. Durable antitumor activity was only … (full text at CIViC) PMID 19553641 · Fong et al., 2009 · Open in CIViC	civic
〃	Malignant Ovarian Neoplasm	Predictive	A	Supports Sensitivity Response	5	accepted	EID7274 In the phase 3 SOLO1 trial 390 patients with newly diagnosed advanced ovarian cancer with a mutation in BRCA1 or BRCA2 who had complete or partial response after platinum-based chemotherapy were rando… (full text at CIViC) PMID 30345884 · Moore et al., 2018 · Open in CIViC	civic
〃	Malignant Ovarian Neoplasm	Predictive	A	Supports Sensitivity Response	1	accepted	EID7275 In the phase 3 SOLO1 trial 390 patients with newly diagnosed advanced ovarian cancer with a mutation in BRCA1 or BRCA2 who had complete or partial response after platinum-based chemotherapy were rando… (full text at CIViC) PMID 30345884 · Moore et al., 2018 · Open in CIViC	civic
〃	Malignant Ovarian Neoplasm	Predictive	B	Supports Sensitivity Response	3	accepted	EID1772 In a study of 63 patients with ovarian cancer, 17 patients had BRCA1 or BRCA2 mutations and 46 patients had no BRCA mutations. Of the BRCA-positive patients, 7/17(41%; 95%CI 22-64) showed objective r… (full text at CIViC) PMID 21862407 · Gelmon et al., 2011 · Open in CIViC	civic
Cediranib + OlaparibCombination	Malignant Ovarian Neoplasm	Predictive	B	Supports Sensitivity Response	3	accepted	EID1677 46 women with platinum-sensitive, high-grade, BRCA1/2+ ovarian cancer received either olaparib monotherapy or olaparib/cediranib combination therapy. Median PFS was increased in combination therapy (… (full text at CIViC) PMID 25218906 · Liu et al., 2014 · Open in CIViC	civic
Rucaparib	Malignant Ovarian Neoplasm	Predictive	A	Supports Sensitivity Response	5	accepted	EID11136 Combined meta-analysis of Study 10 (NCT01482715, phase I/II) and ARIEL2 (NCT01891344, phase II), both multi-centre, open-label, single-arm trials evaluating rucaparib in ovarian cancer with BRCA1 or B… (full text at CIViC) PMID 28882436 · Oza et al., 2017 · Open in CIViC	civic
〃	Malignant Ovarian Neoplasm	Predictive	A	Supports Sensitivity Response	5	accepted	EID11138 Combined meta-analysis of Study 10 (NCT01482715, phase I/II) and ARIEL2 (NCT01891344, phase II), both multi-centre, open-label, single-arm trials evaluating rucaparib in ovarian cancer with BRCA1 or B… (full text at CIViC) PMID 28882436 · Oza et al., 2017 · Open in CIViC	civic
〃	Malignant Ovarian Neoplasm	Predictive	B	Supports Sensitivity Response	3	accepted	EID1897 A phase 2 trial on patients with relapsed, platinum-sensitive high grade ovarian, fallopian tube or primary peritoneal carcinoma (ARIEL2 Part1, NCT01891344) was held to assess PARP inhibitor rucaparib… (full text at CIViC) PMID 27908594 · Swisher et al., 2017 · Open in CIViC	civic
〃	Malignant Ovarian Neoplasm	Predictive	B	Supports Sensitivity Response	3	accepted	EID6341 A phase 2 trial on patients with relapsed, platinum-sensitive high grade ovarian, fallopian tube or primary peritoneal carcinoma (ARIEL2 Part1, NCT01891344) was held to assess PARP inhibitor rucaparib… (full text at CIViC) PMID 27908594 · Swisher et al., 2017 · Open in CIViC	civic
Cisplatin + OxaliplatinSubstitutes	Malignant Pancreatic Neoplasm	Predictive	B	Supports Sensitivity Response	4	accepted	EID5915 Patients with BRCA1/2 associated pancreatic adenocarcinoma were evaluated retrospectively. In patients with stage 3 and 4, the median overall survival (mOS) was 22 months for the platinum exposed (n=2… (full text at CIViC) PMID 25072261 · Golan et al., 2014 · Open in CIViC	civic
Olaparib	Malignant Pancreatic Neoplasm	Predictive	B	Supports Sensitivity Response	3	accepted	EID5914 Twenty-three patients with pancreatic cancer havoring BRCA1/2 germline mutations received olaparib. Five (21.7%) patients had a BRCA1 mutation. All but one had received prior gemcitabine, and 65% had … (full text at CIViC) PMID 25366685 · Kaufman et al., 2015 · Open in CIViC	civic
Veliparib	Malignant Pancreatic Neoplasm	Predictive	B	Does Not Support Sensitivity Response	3	accepted	EID5934 Veliparib 400mg BID was administered to patients with germline BRCA1/2-mutated pancreatic cancer. Sixteen patients were enrolled. All except two (12.5%) had previously been treated with platinum thera… (full text at CIViC) PMID 29223478 · Lowery et al., 2018 · Open in CIViC	civic
Cisplatin + Gemcitabine + VeliparibCombination	Malignant Pancreatic Neoplasm	Predictive	B	Supports Sensitivity Response	3	accepted	EID5932 In Phase I study for pancreatic cancer patients GEM 600 mg/m2 + CDDP 25 mg/m2 + Veliparib 20 - 80 mg twice daily showed response rate of 77.8% (7/9) and mOS of 23.3 months in germline BRCA mutation-p… (full text at CIViC) PMID 29338080 · O'Reilly et al., 2018 · Open in CIViC	civic
Platinum Compound	Ovarian Carcinoma	Predictive	B	Supports Sensitivity Response	3	accepted	EID1529 In a study of ovarian carcinomas, 81% of tumors with germline BRCA1/2 mutations were platinum sensitive, whereas only 60% of tumors with non-BRCA1/2 mutations were platinum sensitive (N=47; N=158; P=0… (full text at CIViC) PMID 24240112 · Pennington et al., 2014 · Open in CIViC	civic
〃	Ovarian Carcinoma	Predictive	B	Supports Sensitivity Response	3	accepted	EID1531 In a study of ovarian carcinomas, 87% of tumors with somatic BRCA1/2 mutations were platinum sensitive, whereas only 60% of tumors with non-BRCA1/2 mutations were platinum sensitive (N=38; N=158; P=0.… (full text at CIViC) PMID 24240112 · Pennington et al., 2014 · Open in CIViC	civic
Carboplatin + CisplatinSubstitutes	Triple-Negative Breast CarcinomaALIAS	Predictive	B	Supports Sensitivity Response	3	accepted	EID1684 In an evaluation of 77 patients, those who had BRCA1/2 germline mutations (n=11) had an increase response rate to cisplatin when compared to those without germline mutations (54.5% versus 19.7%; P=0.0… (full text at CIViC) PMID 25847936 · Isakoff et al., 2015 · Open in CIViC	civic
Olaparib	Triple-Negative Breast CarcinomaALIAS	Predictive	B	Supports Resistance	3	accepted	EID1775 In a study of 26 patients with breast cancer, 10 patients were BRCA-positive and 16 patients were BRCA-negative. Regardless of BRCA status, none showed objective response when treated with olaparib. PMID 21862407 · Gelmon et al., 2011 · Open in CIViC	civic
〃	HER2 Negative Breast CancerUNRESOLVED	Predictive	B	Supports Sensitivity Response	4	accepted	EID5830 Randomized, open-label, phase 3 trial in which olaparib monotherapy was compared with standard therapy in patients with a germline BRCA mutation HER2–negative metastatic breast cancer. 205 patients we… (full text at CIViC) PMID 28792849 · 2017 · Open in CIViC	civic

BRCA1 Mutation19

Predictive

Supports Sensitivity Response

accepted

EID11203

This randomized, open-label, phase 3 trial evaluated the PARP inhibitor olaparib in 387 men with metastatic castration-resistant prostate cancer (mCRPC) who had disease progression while receiving a n… (full text at CIViC)

PMID 32343890 · de Bono et al., 2020 · Open in CIViC

〃

Malignant NeoplasmALIAS

Predictive

Supports Sensitivity Response

accepted

EID1370

In this phase 1 trial, 60 patients with advanced solid tumors (ovarian, breast, colorectal, melanoma, sarcoma, prostate) were treated with PARP inhibitor olaparib. Durable antitumor activity was only … (full text at CIViC)

PMID 19553641 · Fong et al., 2009 · Open in CIViC

〃

Predictive

Supports Sensitivity Response

accepted

EID7274

In the phase 3 SOLO1 trial 390 patients with newly diagnosed advanced ovarian cancer with a mutation in BRCA1 or BRCA2 who had complete or partial response after platinum-based chemotherapy were rando… (full text at CIViC)

PMID 30345884 · Moore et al., 2018 · Open in CIViC

〃

Predictive

Supports Sensitivity Response

accepted

EID7275

PMID 30345884 · Moore et al., 2018 · Open in CIViC

〃

Predictive

Supports Sensitivity Response

accepted

EID1772

In a study of 63 patients with ovarian cancer, 17 patients had BRCA1 or BRCA2 mutations and 46 patients had no BRCA mutations. Of the BRCA-positive patients, 7/17(41%; 95%CI 22-64) showed objective r… (full text at CIViC)

PMID 21862407 · Gelmon et al., 2011 · Open in CIViC

Cediranib + OlaparibCombination

Predictive

Supports Sensitivity Response

accepted

EID1677

46 women with platinum-sensitive, high-grade, BRCA1/2+ ovarian cancer received either olaparib monotherapy or olaparib/cediranib combination therapy. Median PFS was increased in combination therapy (… (full text at CIViC)

PMID 25218906 · Liu et al., 2014 · Open in CIViC

Predictive

Supports Sensitivity Response

accepted

EID11136

Combined meta-analysis of Study 10 (NCT01482715, phase I/II) and ARIEL2 (NCT01891344, phase II), both multi-centre, open-label, single-arm trials evaluating rucaparib in ovarian cancer with BRCA1 or B… (full text at CIViC)

PMID 28882436 · Oza et al., 2017 · Open in CIViC

〃

Predictive

Supports Sensitivity Response

accepted

EID11138

PMID 28882436 · Oza et al., 2017 · Open in CIViC

〃

Predictive

Supports Sensitivity Response

accepted

EID1897

A phase 2 trial on patients with relapsed, platinum-sensitive high grade ovarian, fallopian tube or primary peritoneal carcinoma (ARIEL2 Part1, NCT01891344) was held to assess PARP inhibitor rucaparib… (full text at CIViC)

PMID 27908594 · Swisher et al., 2017 · Open in CIViC

〃

Predictive

Supports Sensitivity Response

accepted

EID6341

PMID 27908594 · Swisher et al., 2017 · Open in CIViC

Cisplatin + OxaliplatinSubstitutes

Predictive

Supports Sensitivity Response

accepted

EID5915

Patients with BRCA1/2 associated pancreatic adenocarcinoma were evaluated retrospectively. In patients with stage 3 and 4, the median overall survival (mOS) was 22 months for the platinum exposed (n=2… (full text at CIViC)

PMID 25072261 · Golan et al., 2014 · Open in CIViC

Predictive

Supports Sensitivity Response

accepted

EID5914

Twenty-three patients with pancreatic cancer havoring BRCA1/2 germline mutations received olaparib. Five (21.7%) patients had a BRCA1 mutation. All but one had received prior gemcitabine, and 65% had … (full text at CIViC)

PMID 25366685 · Kaufman et al., 2015 · Open in CIViC

Veliparib

Predictive

Does Not Support Sensitivity Response

accepted

EID5934

Veliparib 400mg BID was administered to patients with germline BRCA1/2-mutated pancreatic cancer. Sixteen patients were enrolled. All except two (12.5%) had previously been treated with platinum thera… (full text at CIViC)

PMID 29223478 · Lowery et al., 2018 · Open in CIViC

Cisplatin + Gemcitabine + VeliparibCombination

Predictive

Supports Sensitivity Response

accepted

EID5932

In Phase I study for pancreatic cancer patients GEM 600 mg/m2 + CDDP 25 mg/m2 + Veliparib 20 - 80 mg twice daily showed response rate of 77.8% (7/9) and mOS of 23.3 months in germline BRCA mutation-p… (full text at CIViC)

PMID 29338080 · O'Reilly et al., 2018 · Open in CIViC

Platinum Compound

Ovarian Carcinoma

Predictive

Supports Sensitivity Response

accepted

EID1529

In a study of ovarian carcinomas, 81% of tumors with germline BRCA1/2 mutations were platinum sensitive, whereas only 60% of tumors with non-BRCA1/2 mutations were platinum sensitive (N=47; N=158; P=0… (full text at CIViC)

PMID 24240112 · Pennington et al., 2014 · Open in CIViC

〃

Ovarian Carcinoma

Predictive

Supports Sensitivity Response

accepted

EID1531

In a study of ovarian carcinomas, 87% of tumors with somatic BRCA1/2 mutations were platinum sensitive, whereas only 60% of tumors with non-BRCA1/2 mutations were platinum sensitive (N=38; N=158; P=0.… (full text at CIViC)

PMID 24240112 · Pennington et al., 2014 · Open in CIViC

Carboplatin + CisplatinSubstitutes

Triple-Negative Breast CarcinomaALIAS

Predictive

Supports Sensitivity Response

accepted

EID1684

In an evaluation of 77 patients, those who had BRCA1/2 germline mutations (n=11) had an increase response rate to cisplatin when compared to those without germline mutations (54.5% versus 19.7%; P=0.0… (full text at CIViC)

PMID 25847936 · Isakoff et al., 2015 · Open in CIViC

Triple-Negative Breast CarcinomaALIAS

Predictive

Supports Resistance

accepted

EID1775

In a study of 26 patients with breast cancer, 10 patients were BRCA-positive and 16 patients were BRCA-negative. Regardless of BRCA status, none showed objective response when treated with olaparib.

PMID 21862407 · Gelmon et al., 2011 · Open in CIViC

〃

HER2 Negative Breast CancerUNRESOLVED

Predictive

Supports Sensitivity Response

accepted

EID5830

Randomized, open-label, phase 3 trial in which olaparib monotherapy was compared with standard therapy in patients with a germline BRCA mutation HER2–negative metastatic breast cancer. 205 patients we… (full text at CIViC)

PMID 28792849 · 2017 · Open in CIViC

BRCA1 Loss-of-function9
Pidnarulex + QuarfloxinSubstitutes	Malignant Breast Neoplasm	Predictive	D	Supports Sensitivity Response	4	accepted	EID1924 The authors show that in the CX-5461 and CX-3543, G-quadruplex stabilizing agents, demonstrate specific toxicity against BRCA deficient breast cancer derived cells and polyclonal patient-derived xenog… (full text at CIViC) PMID 28211448 · Xu et al., 2017 · Open in CIViC	civic
Talazoparib	Malignant Breast Neoplasm	Predictive	B	Supports Sensitivity Response	4	accepted	EID4838 In part 2 of a two-part dose-escalation phase I trial (NCT01286987), 71 patients with Ewings sarcoma, breast, ovarian, small cell lung, or pancreatic cancers received 1.0 mg/day talazoparib treatment.… (full text at CIViC) PMID 28242752 · de Bono et al., 2017 · Open in CIViC	civic
Olaparib	Malignant Ovarian Neoplasm	Predictive	B	Supports Sensitivity Response	4	accepted	EID211 The combination of PARP inhibition (Olaparib) with BRCA mutation results in irreparable and lethal DNA damage. Response rates are higher in BRCA1 mutation positive women with high grade serous or undi… (full text at CIViC) PMID 23346317 · Goff, 2013 · Open in CIViC	civic
Talazoparib	Malignant Ovarian Neoplasm	Predictive	B	Supports Sensitivity Response	3	accepted	EID4876 In part 2 of a two-part dose-escalation phase I trial (NCT01286987), 71 patients with Ewings sarcoma, breast, ovarian, small cell lung, or pancreatic cancers received 1.0 mg/day talazoparib treatment.… (full text at CIViC) PMID 28242752 · de Bono et al., 2017 · Open in CIViC	civic
Olaparib	Malignant Prostate Neoplasm	Predictive	C	Supports Sensitivity Response	2	accepted	EID845 1/1 patients with BRCA1 homozygous deletion had a response to olaparib in this phase 2 study. PMID 26510020 · Mateo et al., 2015 · Open in CIViC	civic
〃	Pancreatic Adenocarcinoma	Predictive	A	Supports Sensitivity Response	5	accepted	EID7384 In the phase 3 POLO trial patients who had germline BRCA1/2 mutation and metastatic pancreatic adenocarcinoma that had not progressed during first-line platinum-based chemotherapy were allocated to ma… (full text at CIViC) PMID 31157963 · Golan et al., 2019 · Open in CIViC	civic
〃	Triple-Negative Breast CarcinomaALIAS	Predictive	A	Supports Sensitivity Response	5	accepted	EID11216 Report of OlympiA (NCT02032823), a randomized, double-blind, placebo-controlled study of 1836 patients with HER2-negative breast cancer with germline pathogenic or likely pathogenic mutations in BRCA1… (full text at CIViC) PMID 34081848 · Tutt et al., 2021 · Open in CIViC	civic
〃	HER2 Negative Breast CancerUNRESOLVED	Predictive	A	Supports Sensitivity Response	5	accepted	EID11201 Report of OlympiA (NCT02032823), a randomized, double-blind, placebo-controlled study of 1836 patients with HER2-negative breast cancer with germline pathogenic or likely pathogenic mutations in BRCA1… (full text at CIViC) PMID 34081848 · Tutt et al., 2021 · Open in CIViC	civic
〃	HER2 Negative Breast CancerUNRESOLVED	Predictive	B	Supports Sensitivity Response	5	accepted	EID5815 302 patients (234 with progression events) with HER2-negative metastatic breast cancer and with a confirmed deleterious or suspected deleterious germline BRCA mutation (164 BRCA1, 129 BRCA2) had signi… (full text at CIViC) PMID 28578601 · Robson et al., 2017 · Open in CIViC	civic

BRCA1 Loss-of-function9

Pidnarulex + QuarfloxinSubstitutes

Predictive

Supports Sensitivity Response

accepted

EID1924

The authors show that in the CX-5461 and CX-3543, G-quadruplex stabilizing agents, demonstrate specific toxicity against BRCA deficient breast cancer derived cells and polyclonal patient-derived xenog… (full text at CIViC)

PMID 28211448 · Xu et al., 2017 · Open in CIViC

Predictive

Supports Sensitivity Response

accepted

EID4838

In part 2 of a two-part dose-escalation phase I trial (NCT01286987), 71 patients with Ewings sarcoma, breast, ovarian, small cell lung, or pancreatic cancers received 1.0 mg/day talazoparib treatment.… (full text at CIViC)

PMID 28242752 · de Bono et al., 2017 · Open in CIViC

Predictive

Supports Sensitivity Response

accepted

EID211

The combination of PARP inhibition (Olaparib) with BRCA mutation results in irreparable and lethal DNA damage. Response rates are higher in BRCA1 mutation positive women with high grade serous or undi… (full text at CIViC)

PMID 23346317 · Goff, 2013 · Open in CIViC

Predictive

Supports Sensitivity Response

accepted

EID4876

PMID 28242752 · de Bono et al., 2017 · Open in CIViC

Malignant Prostate Neoplasm

Predictive

Supports Sensitivity Response

accepted

EID845

1/1 patients with BRCA1 homozygous deletion had a response to olaparib in this phase 2 study.

PMID 26510020 · Mateo et al., 2015 · Open in CIViC

Pancreatic Adenocarcinoma

〃

Predictive

Supports Sensitivity Response

accepted

EID7384

In the phase 3 POLO trial patients who had germline BRCA1/2 mutation and metastatic pancreatic adenocarcinoma that had not progressed during first-line platinum-based chemotherapy were allocated to ma… (full text at CIViC)

PMID 31157963 · Golan et al., 2019 · Open in CIViC

〃

Triple-Negative Breast CarcinomaALIAS

Predictive

Supports Sensitivity Response

accepted

EID11216

Report of OlympiA (NCT02032823), a randomized, double-blind, placebo-controlled study of 1836 patients with HER2-negative breast cancer with germline pathogenic or likely pathogenic mutations in BRCA1… (full text at CIViC)

PMID 34081848 · Tutt et al., 2021 · Open in CIViC

〃

HER2 Negative Breast CancerUNRESOLVED

Predictive

Supports Sensitivity Response

accepted

EID11201

PMID 34081848 · Tutt et al., 2021 · Open in CIViC

〃

HER2 Negative Breast CancerUNRESOLVED

Predictive

Supports Sensitivity Response

accepted

EID5815

302 patients (234 with progression events) with HER2-negative metastatic breast cancer and with a confirmed deleterious or suspected deleterious germline BRCA mutation (164 BRCA1, 129 BRCA2) had signi… (full text at CIViC)

PMID 28578601 · Robson et al., 2017 · Open in CIViC

BAP1 Loss-of-function + BRCA1 Loss-of-functionBRCA1 BAP11
Rucaparib	Malignant Mesothelioma	Predictive	B	Supports Sensitivity Response	3	accepted	EID11739 In this phase 2a clinical trial, 26 patients with either BRCA1-deficient or BAP1-deficient mesotheliomas were treated with Rucaparib. 38% of the patients were BAP1 and BRCA1 negative, 89% were BAP1 ne… (full text at CIViC) PMID 33515503 · Fennell et al., 2021 · Open in CIViC	civic

BAP1 Loss-of-function + BRCA1 Loss-of-functionBRCA1 BAP11

Malignant Mesothelioma

Predictive

Supports Sensitivity Response

accepted

EID11739

In this phase 2a clinical trial, 26 patients with either BRCA1-deficient or BAP1-deficient mesotheliomas were treated with Rucaparib. 38% of the patients were BAP1 and BRCA1 negative, 89% were BAP1 ne… (full text at CIViC)

PMID 33515503 · Fennell et al., 2021 · Open in CIViC

BRCA1 Expression1
Vinorelbine	Malignant Mesothelioma	Predictive	D	Supports Sensitivity Response	2	accepted	EID933 Expression of BRCA1 in 6 mesothelioma cell lines was associated with sensitivity to vinorelbine in functional studies. PMID 22190288 · Busacca et al., 2012 · Open in CIViC	civic

BRCA1 Expression1

Malignant Mesothelioma

Predictive

Supports Sensitivity Response

accepted

EID933

Expression of BRCA1 in 6 mesothelioma cell lines was associated with sensitivity to vinorelbine in functional studies.

PMID 22190288 · Busacca et al., 2012 · Open in CIViC

BRCA1 Underexpression1
Platinum Compound + Taxane CompoundCombination	Malignant Ovarian Neoplasm	Predictive	B	Supports Sensitivity Response	3	accepted	EID942 Absent/low expression of BRCA1 (IHC) was associated with improved response to chemotherapy in 292 patients with sporadic ovarian cancer compared to patients with high expression (odds ratio 2.47: 95%C… (full text at CIViC) PMID 21920589 · Carser et al., 2011 · Open in CIViC	civic

BRCA1 Underexpression1

Platinum Compound + Taxane CompoundCombination

Predictive

Supports Sensitivity Response

accepted

EID942

Absent/low expression of BRCA1 (IHC) was associated with improved response to chemotherapy in 292 patients with sporadic ovarian cancer compared to patients with high expression (odds ratio 2.47: 95%C… (full text at CIViC)

PMID 21920589 · Carser et al., 2011 · Open in CIViC

BRCA1 Q1467*1

Predictive

Supports Sensitivity Response

—

accepted

EID2878

In a phase 2 study of 206 recurrent, platinum-sensitive, high-grade ovarian cancer patients, patients with germline or somatic BRCA1 or BRCA2 mutation (n=40) were associated with improved progression … (full text at CIViC)

PMID 27908594 · Swisher et al., 2017 · Open in CIViC

BRCA1 W1815X1

Ovarian Endometrioid AdenocarcinomaALIAS

Predictive

Supports Sensitivity Response

accepted

EID4623

In an in vitro study, a SNU-251 cell line expressing BRCA1 W1815X truncating mutation demonstrated increased sensitivity to olaparib treatment with long-term exposure, compared to ovarian cell lines e… (full text at CIViC)

PMID 23415752 · Stordal et al., 2013 · Open in CIViC

Drug

Jurisdiction · authority

Cancer

Indication

Status

Approval date

Source

US FDA

—

Ovarian cancer for the maintenance treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

approved

Dec 19, 2016

US FDA

Prostate cancer for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy. Select patients for therapy based on an FDA-approved companion diagnostic for RUBRACA.

approved

Dec 19, 2016

CA Health Canada

—

Marketed in Canada as TALZENNA (DIN 02555050) under ATC L01XK04 TALAZOPARIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

May 16, 2025

CA Health Canada

—

Marketed in Canada as TALZENNA (DIN 02492032) under ATC L01XK04 TALAZOPARIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

May 16, 2025

CA Health Canada

—

Marketed in Canada as TALZENNA (DIN 02555077) under ATC L01XK04 TALAZOPARIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approved

—

CA Health Canada

—

Marketed in Canada as TALZENNA (DIN 02492040) under ATC L01XK04 TALAZOPARIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approved

—

CA Health Canada

—

Marketed in Canada as TALZENNA (DIN 02555069) under ATC L01XK04 TALAZOPARIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approved

—

EU EMA

—

Treatment with Talzenna should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. Patient selection Breast cancer: Patients should be selected for the treatment of breast cancer with Talzenna based on the presence of deleterious or suspected deleterious germline BRCA mutations determined by an experienced laboratory using a validated test method. Genetic counselling for patients with BRCA mutations should be performed according to local regulations, as applicable. Prostate cancer: There is no requirement for tumour mutation testing for selection of patients with mCRPC for treatment with Talzenna.

approved

Jun 20, 2019

ema

US FDA

—

Efficacy supplement 2025-06-12 (see label)

approved

Jun 12, 2025

US FDA

—

Efficacy supplement 2025-06-12 (see label)

approved

Jun 12, 2025

US FDA

Breast Cancer • As a single agent, for the treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated (g BRCA m) HER2-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA.

approved

Mar 7, 2024

US FDA

HRR Gene-Mutated mCRPC • In combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC).

approved

Mar 7, 2024

US FDA

—

Efficacy supplement 2023-06-20 (see label)

approved

Jun 20, 2023

US FDA

—

Efficacy supplement 2021-09-09 (see label)

approved

Sep 9, 2021

US FDA

—

Efficacy supplement 2020-10-22 (see label)

approved

Oct 22, 2020

US FDA

—

Efficacy supplement 2020-03-09 (see label)

approved

Mar 9, 2020

US FDA

—

Efficacy supplement 2019-09-24 (see label)

approved

Sep 24, 2019

US FDA

HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC) • In combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC).

approved

Oct 16, 2018

US FDA

approved

Oct 16, 2018

CA Health Canada

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Marketed in Canada as VINORELBINE INJECTION, USP (DIN 02511347) under ATC L01CA04 VINORELBINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Jun 25, 2021

CA Health Canada

—

Marketed in Canada as VINORELBINE INJECTION, USP (DIN 02431130) under ATC L01CA04 VINORELBINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Aug 1, 2017

CA Health Canada

—

Marketed in Canada as VINORELBINE INJECTION (DIN 02265990) under ATC L01CA04 VINORELBINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

withdrawnsource: Cancelled Post Marketsince Jul 20, 2021

Mar 31, 2009

CA Health Canada

—

Marketed in Canada as VINORELBINE TARTRATE FOR INJECTION (DIN 02271214) under ATC L01CA04 VINORELBINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

May 9, 2007

CA Health Canada

—

Marketed in Canada as VINORELBINE TARTRATE FOR INJECTION (DIN 02257777) under ATC L01CA04 VINORELBINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

withdrawnsource: Cancelled Post Marketsince Apr 6, 2021

Dec 22, 2004

CA Health Canada

—

Marketed in Canada as NAVELBINE (DIN 02091283) under ATC L01CA04 VINORELBINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

withdrawnsource: Cancelled Post Marketsince Oct 1, 2012

Dec 31, 1994

CA Health Canada

—

Marketed in Canada as VINORELBINE INJECTION, USP (DIN 02392445) under ATC L01CA04 VINORELBINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

withdrawnsource: Cancelled Pre Marketsince Feb 28, 2022

—

CA Health Canada

—

Marketed in Canada as VINORELBINE TARTRATE INJECTION USP (DIN 02327643) under ATC L01CA04 VINORELBINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

withdrawnsource: Cancelled Pre Marketsince Aug 1, 2018

—

CA Health Canada

—

Marketed in Canada as AJ-VINORELBINE (DIN 02396416) under ATC L01CA04 VINORELBINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

withdrawnsource: Cancelled Pre Marketsince Nov 3, 2015

—

Lung Non-Small Cell Carcinoma

US FDA

Vinorelbine injection is indicated: In combination with cisplatin for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) As a single agent for the treatment of patients with metastatic NSCLC Vinorelbine injection is a vinca alkaloid indicated: In combination with cisplatin for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) ( 1 ) As a single agent for first-line treatment of patients with metastatic NSCLC ( 1 )

approved

Jul 22, 2009