BRCA2 mutation

Clinical trials

Active trials (554)

Trials with an active ClinicalTrials.gov status, an intervention mapped to a derived drug and a condition mapped to an associated cancer. 252 recruiting · 96 active phase 3 · 2,259 in any status. Most recently updated first, 50 per page.

Computedrule biomarker-links-v1

clinicaltrialsPublishedShowing 501–550 of 554 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
NCT06662669	YL-13027 and/or HY-0102 Combined With AG Regimen Chemotherapy for Metastatic Pancreatic Cancer	not yet recruiting	Phase 1 / Phase 2	120

Literature

Linked publications (33)

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

pubmedPublishedShowing 26–33 of 33 publications · bibliographic data as recorded by PubMed; abstracts are not reproduced.

Olaparib in Patients With Metastatic Prostate Cancer With BRCA1/2 Mutation: Results From the TAPUR Study.
· JCO Precis Oncol · 2023 · PMID 36753688 · validated civic_curation pubmed
Sequence variant classification and reporting: recommendations for improving the interpretation of cancer susceptibility genetic test results.
· Hum Mutat · 2008 · PMID 18951446 · validated civic_curation pubmed
De novo Alu element insertions targeted to a sequence common to the BRCA1 and BRCA2 genes.
· Hum Mutat · 2005 · PMID 16088935 · validated civic_curation pubmed
Evidence for the efficacy of Iniparib, a PARP-1 inhibitor, in BRCA2-associated pancreatic cancer.
· Anticancer Res · 2011 · PMID 21508395

BRCA2 Mutation19
Olaparib	Castration-Resistant Prostate Carcinoma	Predictive	A	Supports Sensitivity Response	5	accepted	EID8842 In phase 3 trial of 387 patients comparing olaparib and new hormonal agent (enzalutamide or abiraterone) therapy for patients with metastatic castration-resistant prostate cancer harboring homologous … (full text at CIViC) PMID 32343890 · de Bono et al., 2020 · Open in CIViC	civic
〃	Malignant Breast Neoplasm	Predictive	B	Supports Sensitivity Response	4	accepted	EID5831 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
〃	Malignant NeoplasmALIAS	Predictive	B	Supports Sensitivity Response	4	accepted	EID1371 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 o… (full text at CIViC) PMID 19553641 · Fong et al., 2009 · Open in CIViC	civic
〃	Malignant Ovarian Neoplasm	Predictive	A	Supports Sensitivity Response	5	accepted	EID7276 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	EID1773 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	EID1678 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	EID11137 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	EID11139 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	2	accepted	EID2868 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	EID6343 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
Iniparib	Malignant Pancreatic Neoplasm	Predictive	C	Supports Sensitivity Response	3	accepted	EID5936 Patient with germline BRCA2 mutation underwent resection of pancreatic cancer. Around three years later, tumor recurrence was detected by MRI and PET-CT confirmed it. She was treated with gemcitabine … (full text at CIViC) PMID 21508395 · Fogelman et al., 2011 · Open in CIViC	civic
Olaparib	Malignant Pancreatic Neoplasm	Predictive	B	Supports Sensitivity Response	4	accepted	EID5913 Twenty-three patients with pancreatic cancer havoring BRCA1/2 germline mutations received olaparib. Eighteen (78%) patients had a BRCA2 mutation. In total of patients with BRCA1/2 mutation , all but … (full text at CIViC) PMID 25366685 · Kaufman et al., 2015 · Open in CIViC	civic
Platinum Compound	Malignant Pancreatic Neoplasm	Predictive	B	Supports Sensitivity Response	4	accepted	EID5916 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
Veliparib	Malignant Pancreatic Neoplasm	Predictive	B	Does Not Support Sensitivity Response	3	accepted	EID5935 Veliparib 400mg bid was administered to patients with germline BRCA1/2 mutated pancreatic cancer. Sixteen pts was enrolled. All except two pts (12.5%) had previously been treated with platinum therapy… (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	EID5933 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	EID1530 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	EID1532 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	EID1685 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	Does Not Support Sensitivity Response	3	accepted	EID1776 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

BRCA2 Mutation19

Predictive

Supports Sensitivity Response

accepted

EID8842

In phase 3 trial of 387 patients comparing olaparib and new hormonal agent (enzalutamide or abiraterone) therapy for patients with metastatic castration-resistant prostate cancer harboring homologous … (full text at CIViC)

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

〃

Predictive

Supports Sensitivity Response

accepted

EID5831

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

〃

Malignant NeoplasmALIAS

Predictive

Supports Sensitivity Response

accepted

EID1371

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 o… (full text at CIViC)

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

〃

Predictive

Supports Sensitivity Response

accepted

EID7276

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

EID1773

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

EID1678

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

EID11137

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

EID11139

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

〃

Predictive

Supports Sensitivity Response

accepted

EID2868

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

EID6343

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

Iniparib

Predictive

Supports Sensitivity Response

accepted

EID5936

Patient with germline BRCA2 mutation underwent resection of pancreatic cancer. Around three years later, tumor recurrence was detected by MRI and PET-CT confirmed it. She was treated with gemcitabine … (full text at CIViC)

PMID 21508395 · Fogelman et al., 2011 · Open in CIViC

Predictive

Supports Sensitivity Response

accepted

EID5913

Twenty-three patients with pancreatic cancer havoring BRCA1/2 germline mutations received olaparib. Eighteen (78%) patients had a BRCA2 mutation. In total of patients with BRCA1/2 mutation , all but … (full text at CIViC)

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

Platinum Compound

Predictive

Supports Sensitivity Response

accepted

EID5916

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

Veliparib

Predictive

Does Not Support Sensitivity Response

accepted

EID5935

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

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

Cisplatin + Gemcitabine + VeliparibCombination

Predictive

Supports Sensitivity Response

accepted

EID5933

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

EID1530

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

EID1532

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

EID1685

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

Does Not Support Sensitivity Response

accepted

EID1776

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

BRCA2 K3326*1
Olaparib + TemozolomideCombination	GlioblastomaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	3	accepted	EID7724 In a case report, a 3‐year‐old girl with glioblastoma harboring a probable germline heterozygous BRCA2 Lys3326Ter (K3326*) nonsense variant. After debulking surgery, the patient received standard‐of‐c… (full text at CIViC) PMID 32043779 · Valiakhmetova et al., 2020 · Open in CIViC	civic

BRCA2 K3326*1

Olaparib + TemozolomideCombination

GlioblastomaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID7724

In a case report, a 3‐year‐old girl with glioblastoma harboring a probable germline heterozygous BRCA2 Lys3326Ter (K3326*) nonsense variant. After debulking surgery, the patient received standard‐of‐c… (full text at CIViC)

PMID 32043779 · Valiakhmetova et al., 2020 · Open in CIViC

BRCA2 Loss-of-function10
Pidnarulex + QuarfloxinSubstitutes	Malignant Breast Neoplasm	Predictive	D	Supports Sensitivity Response	4	accepted	EID1925 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	EID4839 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	EID212 The combination of PARP inhibition (Olaparib) with BRCA mutation results in irreparable and lethal DNA damage. Response rates are higher in BRCA2 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	EID4875 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
Mitomycin	Malignant Pancreatic Neoplasm	Predictive	D	Supports Sensitivity Response	2	accepted	EID1308 In pancreatic cell lines PL11 (FANCC-deficient) and CAPAN1 (BRCA2-mutated), sensitivity to DNA cross-linking agents was observed compared to FANCC/BRCA2 wildtype cell lines (Su86.86, CFPAC, AsPc1, and… (full text at CIViC) PMID 16243825 · van der Heijden et al., 2005 · Open in CIViC	civic
Olaparib	Malignant Prostate Neoplasm	Predictive	B	Supports Sensitivity Response	4	accepted	EID650 In a phase 2 trial of patients with metastatic, castration-resistant prostate cancer, treated with olaparib tablets at a dose of 400 mg twice a day, all 7 patients harbouring BRCA2 loss of function al… (full text at CIViC) PMID 26510020 · Mateo et al., 2015 · Open in CIViC	civic
〃	Pancreatic Adenocarcinoma	Predictive	A	Supports Sensitivity Response	5	accepted	EID7385 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	EID11217 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	EID11202 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	3	accepted	EID5816 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

BRCA2 Loss-of-function10

Pidnarulex + QuarfloxinSubstitutes

Predictive

Supports Sensitivity Response

accepted

EID1925

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

EID4839

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

EID212

The combination of PARP inhibition (Olaparib) with BRCA mutation results in irreparable and lethal DNA damage. Response rates are higher in BRCA2 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

EID4875

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

Mitomycin

Predictive

Supports Sensitivity Response

accepted

EID1308

In pancreatic cell lines PL11 (FANCC-deficient) and CAPAN1 (BRCA2-mutated), sensitivity to DNA cross-linking agents was observed compared to FANCC/BRCA2 wildtype cell lines (Su86.86, CFPAC, AsPc1, and… (full text at CIViC)

PMID 16243825 · van der Heijden et al., 2005 · Open in CIViC

Malignant Prostate Neoplasm

Predictive

Supports Sensitivity Response

accepted

EID650

In a phase 2 trial of patients with metastatic, castration-resistant prostate cancer, treated with olaparib tablets at a dose of 400 mg twice a day, all 7 patients harbouring BRCA2 loss of function al… (full text at CIViC)

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

Pancreatic Adenocarcinoma

〃

Predictive

Supports Sensitivity Response

accepted

EID7385

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

EID11217

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

EID11202

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

〃

HER2 Negative Breast CancerUNRESOLVED

Predictive

Supports Sensitivity Response

accepted

EID5816

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

BRCA2 M1R1
Rucaparib	Malignant Ovarian Neoplasm	Predictive	C	Supports Sensitivity Response	—	accepted	EID2879 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	civic

BRCA2 M1R1

Predictive

Supports Sensitivity Response

—

accepted

EID2879

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

BRCA2 M1?1
Rucaparib	Malignant Ovarian Neoplasm	Predictive	C	Supports Sensitivity Response	—	accepted	EID2880 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	civic

BRCA2 M1?1

Predictive

Supports Sensitivity Response

—

accepted

EID2880

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

BRCA2 V159M1
Rucaparib	Malignant Ovarian Neoplasm	Predictive	C	Supports Sensitivity Response	—	accepted	EID2881 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	civic

BRCA2 V159M1

Predictive

Supports Sensitivity Response

—

accepted

EID2881

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

BRCA2 V211L1
Rucaparib	Malignant Ovarian Neoplasm	Predictive	C	Supports Sensitivity Response	—	accepted	EID2882 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	civic

BRCA2 V211L1

Predictive

Supports Sensitivity Response

—

accepted

EID2882

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

BRCA2 V211I1
Rucaparib	Malignant Ovarian Neoplasm	Predictive	C	Supports Sensitivity Response	4	accepted	EID2883 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	civic

BRCA2 V211I1

Predictive

Supports Sensitivity Response

accepted

EID2883

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

BRCA2 R2336P1
Rucaparib	Malignant Ovarian Neoplasm	Predictive	C	Supports Sensitivity Response	—	accepted	EID2884 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	civic

BRCA2 R2336P1

Predictive

Supports Sensitivity Response

—

accepted

EID2884

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

Drug

Jurisdiction · authority

Cancer

Indication

Status

Approval date

Source

Niraparib

US FDA

for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA‑authorized companion diagnostic for ZEJULA.

approved

Apr 26, 2023

Niraparib

US FDA

for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either: o a deleterious or suspected deleterious BRCA mutation, and/or o genomic instability. Select patients for therapy based on an FDA‑authorized companion diagnostic for ZEJULA.

approved

Apr 26, 2023

CA Health Canada

—

Marketed in Canada as LYNPARZA (DIN 02475219) under ATC L01XK01 OLAPARIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

May 23, 2018

CA Health Canada

—

Marketed in Canada as LYNPARZA (DIN 02475200) under ATC L01XK01 OLAPARIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

May 23, 2018

CA Health Canada

—

Marketed in Canada as LYNPARZA (DIN 02454408) under ATC L01XK01 OLAPARIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

withdrawnsource: Cancelled Post Marketsince Jan 11, 2021

May 16, 2016

EU EMA

—

Ovarian cancer Lynparza is indicated as monotherapy for the: maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy. Lynparza in combination with bevacizumab is indicated for the: maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a BRCA1/2 mutation and/or genomic instability (see section 5.1). Breast cancer Lynparza is indicated as: monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have HER2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4.2 and 5.1). monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2 negative locally advanced or metastatic breast cancer. Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments (see section 5.1). Patients with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy. Adenocarcinoma of the pancreas Lynparza is indicated as: monotherapy for the maintenance treatment of adult patients with germline BRCA1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. Prostate cancer Lynparza is indicated as: monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent. in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mCRPC in whom chemotherapy is not clinically indicated (see section 5.1). Endometrial cancer Lynparza in combination with durvalumab is indicated for the maintenance treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair proficient (pMMR) whose disease has not progressed on first-line treatment with durvalumab in combination with carboplatin and paclitaxel.

US FDA

—

Efficacy supplement 2023-11-06 (see label)

approved

Nov 6, 2023

US FDA

—

Efficacy supplement 2023-05-31 (see label)

approved

May 31, 2023

US FDA

—

Efficacy supplement 2022-08-26 (see label)

approved

Aug 26, 2022

US FDA

—

Efficacy supplement 2022-03-11 (see label)

approved

Mar 11, 2022

US FDA

—

Efficacy supplement 2022-01-31 (see label)

approved

Jan 31, 2022

US FDA

—

Efficacy supplement 2021-03-11 (see label)

approved

Mar 11, 2021

US FDA

—

Efficacy supplement 2020-12-07 (see label)

approved

Dec 7, 2020

US FDA

—

Efficacy supplement 2020-05-19 (see label)

approved

May 19, 2020

US FDA

—

Efficacy supplement 2020-05-08 (see label)

approved

May 8, 2020

US FDA

—

Efficacy supplement 2019-12-27 (see label)

approved

Dec 27, 2019

US FDA

—

Efficacy supplement 2019-07-01 (see label)

approved

Jul 1, 2019

US FDA

—

Efficacy supplement 2018-12-19 (see label)

approved

Dec 19, 2018

US FDA

—

Efficacy supplement 2018-09-26 (see label)

approved

Sep 26, 2018

US FDA

—

Efficacy supplement 2018-01-12 (see label)

approved

Jan 12, 2018

US FDA

Prostate cancer • for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.

approved

Aug 17, 2017

US FDA

Breast cancer • for the adjuvant treatment of adult patients with deleterious or suspected deleterious g BRCA m human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.

approved

Aug 17, 2017

US FDA

in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.

approved

Aug 17, 2017

US FDA

—

Ovarian cancer • for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA -mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.

approved

Aug 17, 2017

US FDA

in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either: • a deleterious or suspected deleterious BRCA mutation, and/or • genomic instability. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.

approved

Aug 17, 2017

US FDA

for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.

approved

Aug 17, 2017

Pancreatic Adenocarcinoma

US FDA

Pancreatic cancer • for the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCA m metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.

approved

Aug 17, 2017

Hormone Receptor-Positive Breast Carcinoma

US FDA

for the treatment of adult patients with deleterious or suspected deleterious gBRCA m, HER2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.

approved

Aug 17, 2017

EU EMA

Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with advanced (FIGO Stages III and IV) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.

approved

May 23, 2018

ema

US FDA

—

Efficacy supplement 2025-12-17 (see label)

approved

Dec 17, 2025

US FDA

—

Efficacy supplement 2025-12-17 (see label)

approved

Dec 17, 2025

US FDA

—

Efficacy supplement 2022-12-21 (see label)

approved

Dec 21, 2022

US FDA

—

Efficacy supplement 2022-06-10 (see label)

approved

Jun 10, 2022

US FDA

—

Efficacy supplement 2020-10-08 (see label)

approved

Oct 8, 2020

US FDA

—

Efficacy supplement 2020-05-15 (see label)

approved

May 15, 2020

US FDA

—

Efficacy supplement 2018-04-06 (see label)

approved

Apr 6, 2018

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

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

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 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 02555069) 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 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

—

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

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

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

—

Efficacy supplement 2023-06-20 (see label)

approved

Jun 20, 2023

US FDA

—

Efficacy supplement 2021-09-09 (see label)

approved

Sep 9, 2021