Biomarker · Gene alteration

BRCA2 mutation

Pathogenic germline or somatic BRCA2 variants detected by sequencing of blood or tumor; used as a predictive marker for PARP inhibitors and as a hereditary cancer-risk marker.

CI-BIO-00000033BRCA2 graph →NCIt C19636

Also calledBRCA2-mutated · gBRCA2 · germline BRCA2 · somatic BRCA2

Derived

Associated cancers (15)

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 Ovarian Neoplasm	16	15	1	—	3 / 7 / 6 / 0 / 0
Malignant Pancreatic Neoplasm	6	6	—	—	0 / 4 / 1 / 1 / 0
Ovarian Carcinoma	4	3	1	—	1 / 3 / 0 / 0 / 0
Malignant Breast Neoplasm	3	3	—	—	0 / 2 / 0 / 1 / 0
Malignant Prostate Neoplasm

Derived

Drugs with predictive evidence (15)

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
OlaparibSmall Molecule	21	21	—	A	20 / 0	Breast Carcinoma, Castration-Resistant Prostate Carcinoma, Glioblastoma, Lung Carcinoma +10
RucaparibSmall Molecule	11	11	—	A

Curated evidence

Predictive evidence items (44)

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

civicCuratedShowing 1–44 of 44 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
BRCA1 Mutation + BRCA2 MutationBRCA2 BRCA1

Regulatory

Approvals mentioning the linked drugs (223)

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

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 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

Drug	Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
Carboplatin	US FDA	Ovarian Carcinoma	As part of a combination regimen, for the initial treatment of advanced ovarian carcinoma.	approved	Aug 8, 2025	openfda
Carboplatin	US FDA	Ovarian Carcinoma	As a single-agent for the treatment of ovarian carcinoma recurrent after prior chemotherapy.	approved	Aug 8, 2025	openfda
Cisplatin	US FDA	—	Efficacy supplement 1993-04-22 (see label)	approved	Apr 22, 1993	openfda
Cisplatin	US FDA	—	Efficacy supplement 1981-12-29 (see label)	approved	Dec 29, 1981	openfda
Cisplatin	US FDA	Malignant Bladder Neoplasm	INDICATIONS Cisplatin Injection is indicated as therapy to be employed as follows: Metastatic Testicular Tumors In established combination therapy with other approved chemotherapeutic agents in patients with metastatic testicular tumors who have already received appropriate surgical and/or radiotherapeutic procedures. Metastatic Ovarian Tumors In established combination therapy with other approved chemotherapeutic agents in patients with metastatic ovarian tumors who have already received appropriate surgical and/or radiotherapeutic procedures. An established combination consists of Cisplatin Injection and cyclophosphamide. Cisplatin Injection, as a single agent, is indicated as secondary therapy in patients with metastatic ovarian tumors refractory to standard chemotherapy who have not previously received Cisplatin Injection therapy. Advanced Bladder Cancer Cisplatin Injection is indicated as a single agent for patients with transitional cell bladder cancer which is no longer amenable to local treatments, such as surgery and/or radiotherapy.	approved	Dec 19, 1978	openfda
Gemcitabine	US FDA	Non-Muscle Invasive Bladder Carcinoma	INLEXZO is indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. INLEXZO is a nucleoside metabolic inhibitor-containing intravesical system, indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. ( 1 )	approved	Sep 9, 2025	openfda
Gemcitabine	US FDA	Malignant Ovarian Neoplasm	in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.	approved	Jun 27, 2025	openfda
Gemcitabine	US FDA	Malignant Breast Neoplasm	in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.	approved	Jun 27, 2025	openfda
Gemcitabine	US FDA	Lung Non-Small Cell Carcinoma	in combination with cisplatin, for the treatment of non-small cell lung cancer.	approved	Jun 27, 2025	openfda
Gemcitabine	US FDA	Malignant Pancreatic Neoplasm	as a single agent for the treatment of pancreatic cancer.	approved	Jun 27, 2025	openfda
Gemcitabine	US FDA	Malignant Pancreatic Neoplasm	as a single agent for the treatment of pancreatic cancer.	approved	Aug 3, 2017	openfda
Gemcitabine	US FDA	Malignant Ovarian Neoplasm	in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.	approved	Aug 3, 2017	openfda
Gemcitabine	US FDA	Malignant Breast Neoplasm	in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.	approved	Aug 3, 2017	openfda
Gemcitabine	US FDA	Lung Non-Small Cell Carcinoma	in combination with cisplatin for the treatment of non-small cell lung cancer.	approved	Aug 3, 2017	openfda
Gemcitabine	US FDA	Lung Non-Small Cell Carcinoma	in combination with cisplatin for the treatment of non-small cell lung cancer.	approved	Aug 4, 2011	openfda
Gemcitabine	US FDA	Malignant Ovarian Neoplasm	in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.	approved	Aug 4, 2011	openfda
Gemcitabine	US FDA	Malignant Breast Neoplasm	in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.	approved	Aug 4, 2011	openfda
Gemcitabine	US FDA	Malignant Pancreatic Neoplasm	as a single agent for the treatment of pancreatic cancer.	approved	Aug 4, 2011	openfda
Mitomycin	US FDA	Non-Muscle Invasive Bladder Carcinoma	ZUSDURI™ is indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). ZUSDURI is an alkylating drug indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). ( 1 )	approved	Jun 12, 2025	openfda
Mitomycin	US FDA	—	JELMYTO ® is indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC). JELMYTO is an alkylating drug indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC). ( 1 )	approved	Apr 15, 2020	openfda
Mitomycin	US FDA	—	Mitosol ® is an antimetabolite indicated for use as an adjunct to ab externo glaucoma surgery. Mitosol ® is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery. ( 1 )	approved	Feb 7, 2012	openfda
Niraparib	US FDA	—	Efficacy supplement 2025-06-18 (see label)	approved	Jun 18, 2025	openfda
Niraparib	US FDA	Malignant Peritoneal Neoplasm	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	openfda
Niraparib	US FDA	Malignant Peritoneal Neoplasm	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	openfda
Olaparib	US FDA	—	Efficacy supplement 2023-11-06 (see label)	approved	Nov 6, 2023	openfda
Olaparib	US FDA	—	Efficacy supplement 2023-05-31 (see label)	approved	May 31, 2023	openfda
Olaparib	US FDA	—	Efficacy supplement 2022-08-26 (see label)	approved	Aug 26, 2022	openfda
Olaparib	US FDA	—	Efficacy supplement 2022-03-11 (see label)	approved	Mar 11, 2022	openfda
Olaparib	US FDA	—	Efficacy supplement 2022-01-31 (see label)	approved	Jan 31, 2022	openfda
Olaparib	US FDA	—	Efficacy supplement 2021-03-11 (see label)	approved	Mar 11, 2021	openfda
Olaparib	US FDA	—	Efficacy supplement 2020-12-07 (see label)	approved	Dec 7, 2020	openfda
Olaparib	US FDA	—	Efficacy supplement 2020-05-19 (see label)	approved	May 19, 2020	openfda
Olaparib	US FDA	—	Efficacy supplement 2020-05-08 (see label)	approved	May 8, 2020	openfda
Olaparib	US FDA	—	Efficacy supplement 2019-12-27 (see label)	approved	Dec 27, 2019	openfda
Olaparib	US FDA	—	Efficacy supplement 2019-07-01 (see label)	approved	Jul 1, 2019	openfda
Olaparib	US FDA	—	Efficacy supplement 2018-12-19 (see label)	approved	Dec 19, 2018	openfda
Olaparib	US FDA	—	Efficacy supplement 2018-09-26 (see label)	approved	Sep 26, 2018	openfda
Olaparib	US FDA	—	Efficacy supplement 2018-01-12 (see label)	approved	Jan 12, 2018	openfda
Olaparib	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	openfda
Olaparib	US FDA	Castration-Resistant Prostate Carcinoma	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	openfda
Olaparib	US FDA	Malignant Breast Neoplasm	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	openfda
Olaparib	US FDA	Malignant Peritoneal Neoplasm	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	openfda
Olaparib	US FDA	Malignant Peritoneal Neoplasm	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	openfda
Olaparib	US FDA	Castration-Resistant Prostate Carcinoma	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	openfda
Olaparib	US FDA	Hormone Receptor-Positive Breast Carcinoma	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	openfda
Olaparib	US FDA	Pancreatic Adenocarcinoma	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	openfda
Rucaparib	US FDA	—	Efficacy supplement 2025-12-17 (see label)	approved	Dec 17, 2025	openfda
Rucaparib	US FDA	—	Efficacy supplement 2025-12-17 (see label)	approved	Dec 17, 2025	openfda
Rucaparib	US FDA	—	Efficacy supplement 2022-12-21 (see label)	approved	Dec 21, 2022	openfda
Rucaparib	US FDA	—	Efficacy supplement 2022-06-10 (see label)	approved	Jun 10, 2022	openfda

Associated cancers (15)

Drugs with predictive evidence (15)

Predictive evidence items (44)

Approvals mentioning the linked drugs (223)

Active trials (554)

Linked publications (33)