Update: PARP inhibitors, rucaparib (Rubraca) and olaparib (Lynparza) receive FDA approval for metastatic prostate cancer
The FDA approved two PARP inhibitors, rucaparib (Rubraca) and olaparib (Lynparza) for treatment of metastatic castration-resistant prostate cancer (mCRPC) in men who have certain inherited mutations or tumor mutations. (6/1/20)
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The FDA approved two PARP inhibitors, rucaparib (Rubraca) and olaparib (Lynparza) for treatment of metastatic castration-resistant prostate cancer (mCRPC) in men who have certain inherited mutations or tumor mutations. (6/1/20)
Most relevant for: Men with metastatic castration-resistant prostate cancer who have certain inherited or tumor mutations in DNA repair genes.
It may also be relevant for:
- people with metastatic or advanced cancer
- people with a genetic mutation linked to cancer risk
Relevance: High
Research Timeline: Post Approval
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First PARP inhibitor approved for metastatic prostate cancer
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Contents
| At a glance | Questions for your doctor |
| What does this mean for me? | In-depth |
| Clinical trials | Resources |
| Guidelines |
APPROVALS AT A GLANCE
The approved use of the PARP inhibitors () and (Lynparza) for treatment of men with castration-resistant cancer (mCRPC) who have certain inherited or tumor mutations.
Why are these FDA approvals important?
These mark the first FDA approvals of PARP inhibitors to treat prostate cancer. Until now, treatment options for men with mCRPC have been limited to hormone therapy, radiation, chemotherapy, and . The addition of PARP inhibitors offers a new treatment option for some men with mCRPC.
PARP inhibitors have already been approved to treat metastatic breast cancer, pancreatic cancer and advanced ovarian cancer.
What do the FDA approvals say?
Rucaparib (Rubraca)
The FDA granted approval of Rubraca for treatment of men with mCRPC who have one of the following mutations:
- an inherited or mutation
- an acquired BRCA1 or BRCA2 mutation in their tumor
Men are eligible for Rubraca if they have already been treated with androgen deprivation (hormone therapy) and a taxane-based chemotherapy.
Olaparib (Lynparza)
The FDA granted approval of Lynparza for treatment of men with mCRPC who have either:
- an inherited BRCA1 or BRCA2 mutation
- an acquired mutation in their tumor in any of the following genes associated with a type of repair called " repair" (HRR):
- , BRCA1, BRCA2, , , CDK12, CHEK1, , FANCL, , RAD51B, , , RAD54L
Men with mCRPC are eligible for Lynparza if their cancer has progressed following treatment with (Xtandi) or (Zytiga).
What does this mean for me?
If you have mCRPC and you have already received hormone therapy and chemotherapy, you may benefit from treatment with a if you have an inherited mutation, or a mutation in a gene involved in homologous recombination repair (HRR) found with tumor testing.
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Posted 6/1/20
References
FDA grants accelerated approval to rucaparib for BRCA-mutated metastatic castration-resistant prostate cancer. FDA website, May, 2020.
FDA approves olaparib for HRR gene-mutated metastatic castration-resistant prostate cancer. FDA website, May 2020.
Disclosure
FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board prior to publication to assure scientific integrity.
Expert Guidelines
The National Comprehensive Cancer Network guidelines recommend genetic counseling and testing for the following people with prostate cancer who have:
- a tumor test result that suggests an inherited mutation
- for example, a tumor with a BRCA1, BRCA2 or ATM mutation may indicate an in one of those genes
- a blood relative who tested positive for an inherited mutation in a gene linked to prostate cancer
- metastatic prostate cancer diagnosed at any age
- prostate cancer that has spread to the
- localized prostate cancer (hasn’t spread beyond the prostate) that is considered very high-risk or high-risk
- intermediate-risk prostate cancer with intraductal or cribriform features listed on the
- a diagnosis of male breast cancer
- Eastern European (Ashkenazi) Jewish ancestry
- one or more relatives with:
- breast, colorectal or endometrial cancer diagnosed at age 50 or younger
- male breast cancer, triple negative breast cancer, ovarian cancer or pancreatic cancer at any age
- metastatic, regional, very-high-risk, or high-risk prostate cancer at any age
- one or more close relatives with prostate cancer diagnosed at age 60 or younger
- three or more relatives on the same side of the family with biliary tract, breast, colorectal, endometrial, glioblastoma, prostate or other cancers
Speak with a genetic counselor if you have questions about whether you meet guidelines for genetic testing.
Updated: 02/01/2024
Expert Guidelines
The National Comprehensive Cancer Network (NCCN) recommends tumor testing to help guide treatment for people with metastatic prostate cancer.
- Testing for MSI-H/dMMR may help identify patients who would benefit from immunotherapy.
- Testing for tumor mutations in HRR genes may help identify patients who would benefit from PARP inhibitors.
- Consider testing for a marker known as (TMB). People with a high tumor mutational burden (TMB-H) may benefit from immunotherapy.
Updated: 03/01/2023
Questions To Ask Your Doctor
- Am I eligible for treatment with a PARP inhibitor?
- Given my personal or family history, should I have genetic testing for an inherited mutation
- Should I have tumor biomarker testing?
- What are the risk and benefits of taking a PARP inhibitor?
- Will my insurance cover treatment with a PARP inhibitor?
- How much will my treatment cost?
Open Clinical Trials
The following studies look at PARP inhibitors and similar agents for treating people with advanced prostate cancer:
- NCT05932862: Study of a New InvestigationaI Inhibitor to Treat People with Advanced . The study examines the safety and effectiveness of the investigational treatment XL309 when used alone or in combination with a PARP inhibitor to treat people with some advanced solid tumors, including prostate cancer.
- NCT05005728: XmAb®20717 Alone or in Combination With Chemotherapy or in Patients With Metastatic Castration-Resistant Prostate Cancer. This study looks at the safety and clinical activity of the drug XmAb20717 alone or in combination with standard-of-care anticancer therapies in patients with metastatic castration-resistant prostate cancer who have been treated with at least 2 prior lines of treatment.
- NCT05417594: Study of the PARP inhibitor AZD9574 Alone and Combined with Other Cancer Medicines to Treat People with Advanced Solid Cancers (CERTIS1 Study). This study looks at a new PARP inhibitor AZD9574 given alone and in combination with other anti-cancer drugs for people with advanced cancer that has come back or progressed.
Other clinical trials for people with prostate cancer can be found here.
Updated: 11/03/2024
Open Clinical Trials
The following studies look at treatment for people with advanced solid tumors.
- NCT02264678: Ascending Doses of Ceralasertib in Combination With Chemotherapy and/or Novel Anti Cancer Agents. This is a study of orally administered ceralasertib combined with chemotherapy regimens and/or novel anticancer agents for patients with advanced cancer. The study enrolls people with tumors that are HRD-positive or who have inherited mutations in BRCA1, BRCA2, ATM, RAD51C or RAD51D.
- NCT04644068: Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies (PETRA). This research is designed to learn whether treatment with a new PARP inhibitor, AZD5305, used alone or in combination with anti-cancer agents is safe, tolerable and has anti-cancer activity in patients with advanced solid tumors. The study is open to people who have previously been treated with PARP inhibitors.
- NCT04267939: ATR Inhibitor Plus Study in Advanced Solid Tumors and Ovarian Cancer. This study looks at how well people with advanced solid tumors respond to treatment with the targeted therapy BAY1895344 in combination with the PARP inhibitor niraparib. This study is open to people with inherited mutations in ATM, BRCA1, BRCA2 and other genes. Contact the study coordinator for information about eligibility for people with mutations in other genes.
- NCT04657068: Treatment with ATR Inhibitor for Advanced or Metastatic Solid Tumors. This study looks at how well a new oral targeted therapy known as an ATR inhibitor works on advanced or metastatic solid tumors with mutations in genes that are linked to DNA damage repair. This study is open to people who have an inherited or acquired BRCA or ATM mutation or whose tumors are HRD-positive. This study is open to people whose cancer stopped responding or progressed on PARP inhibitors.
Updated: 03/28/2025
Peer Support
The following organizations offer peer support services for people with or at high risk for prostate cancer:
- FORCE peer support
- Visit our message boards.
- Once you register, you can post on the Diagnosed With Cancer board to connect with other people who have been diagnosed.
- Sign up for our Peer Navigation Program.
- Users are matched with a volunteer who shares their mutation and situation.
- Join our private Facebook group.
- Find a virtual or in-person support meeting.
- Join a Zoom community group meeting.
- Visit our message boards.
- ZERO-The End of Prostate Cancer is a nonprofit organization that provides information and support resources for men with prostate cancer.
Updated: 03/08/2023
Related Resources
The following resources focus on prostate cancer.
- FORCE prostate cancer resources:
- Advocacy groups:
- National Comprehensive Cancer Network free patient guides:
Updated: 01/30/2025
Who covered this study?
Medscape
First PARP inhibitor approved for metastatic prostate cancer
This article rates 4.0 out of
5 stars
Motley Fool
FDA approves new prostate cancer treatment from AstraZeneca and Merck
This article rates 3.0 out of
5 stars