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Update: PARP inhibitors, rucaparib (Rubraca) and olaparib (Lynparza) receive FDA approval for metastatic prostate cancer

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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 approvals important? 

These mark the first approvals of PARP inhibitors to treat 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 breast cancer, pancreatic cancer and advanced ovarian cancer. 

What do the approvals say? 


The granted approval of for treatment of men with mCRPC who have one of the following mutations:

  • an inherited or  mutation 
  • an acquired or  mutation in their tumor

Men are eligible for if they have already been treated with androgen deprivation (hormone therapy) and a taxane-based chemotherapy. 


The granted approval of Lynparza for treatment of men with mCRPC who have either: 

  • an inherited or mutation
  • an acquired mutation in their tumor in any of the following genes associated with a type of repair called " repair" (HRR):
    • , , , , , 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  repair (HRR) found with tumor testing. 

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Posted 6/1/20


grants accelerated approval to for BRCA-mutated castration-resistant cancer. website, May, 2020.

approves for HRR gene-mutated castration-resistant cancer. website, May 2020.


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.

This article is relevant for:

Men with metastatic castration-resistant prostate cancer who have certain inherited or tumor mutations in DNA repair genes

This article is also relevant for:

people with metastatic or advanced cancer

people with a genetic mutation linked to cancer risk

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Approval of was based on preliminary results from the ongoing (not recruiting) TRITON2 clinical trial.

  • Among the patients with a mutation:
    • 43.9% had a confirmed overall response rate (percentage of patients whose cancer shrinks or disappears) most of which lasted more than 24 weeks.
    • 52.0% had a confirmed response (great than 50% decrease in levels) with a median duration of response of 5.5 months.
  • Among patients with an , or CDK12 mutation both  overall response and response were poor. Overall response for was:
    • 9% for patients with an mutation
    • 0% for patients with a or CDK12 mutation.

​PSA response was:

  • 3.5% for patients with an mutation
  • 7.1% for patients with a CDK12 mutation
  • 14.3% for

The most common side effects of included:

  • Fatigue
  • Nausea
  • Anemia
  • Decreased appetite
  • Constipation
  • Rash
  • Vomiting
  • Diarrhea
  • Increased liver enzymes

 has already received approval for treatment of select patients with advanced ovarian cancer. 


Approval of Lynparza was based on the PROfound clinical trial which showed:

  • Progression-free survival was significantly longer for participants in the group (7.4 months) compared to the control group (3.6 months).
  • Time to pain progression was significantly longer in the group than the control group.
  • Overall survival was longer for patients in the group (18.5 months) compared to the control group (15.1 months),  although at the time the analysis was done, this difference was not statistically significant.

The most common side effects of Lynparza included:

  • Anemia
  • Nausea
  • Fatigue
  • Decreased appetite
  • Diarrhea
  • Vomiting
  • Thrombocytopenia (low blood platelets or white blood cells)
  • Cough
  • Dyspnea or shortness of breadh

Lynparza has already received approval for treatment of select patients with advanced ovarian, pancreatic and breast cancer. 


Expert Guidelines
Expert Guidelines

The National Comprehensive Cancer Network guidelines recommend genetic counseling and testing for the following people with  cancer who have:

  • a tumor test result that suggests an inherited mutation
    • for example, a tumor with a  or  mutation may indicate an in one of those genes 
  • a blood relative who tested positive for an  in a gene linked to  cancer
  •   cancer diagnosed at any age
  • cancer that has spread to the
  • localized cancer (hasn’t spread beyond the ) that is considered very high-risk or high-risk
  • intermediate-risk 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
    • , regional, very-high-risk, or high-risk cancer at any age
  • one or more close relatives with 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, 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
Expert Guidelines

The National Comprehensive Cancer Network (NCCN) recommends tumor testing to help guide treatment for people with prostate cancer.

  • Testing for MSI-H/dMMR may help identify patients who would benefit from .  
  • 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 (TMB-H) may benefit from

Updated: 03/01/2023

Questions To Ask Your Doctor
Questions To Ask Your Doctor

  • Am I eligible for treatment with a ?
  • Given my personal or family history, should I have genetic testing for an
  • Should I have tumor testing?
  • What are the risk and benefits of taking a ?
  • Will my insurance cover treatment with a ?
  • How much will my treatment cost? 

Open Clinical Trials
Open Clinical Trials

The following studies are looking at PARP inhibitors and similar agents for treating people with advanced  cancer.  

Other clinical trials for people with  cancer can be found here.

Updated: 11/09/2023

Open Clinical Trials
Open Clinical Trials

The following studies are looking at treatment for people with advanced


Updated: 02/01/2024

Peer Support
Peer Support

The following organizations offer peer support services for people with or at high risk for cancer:

Updated: 03/08/2023

Who covered this study?


First PARP inhibitor approved for metastatic prostate cancer This article rates 4.0 out of 5 stars

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FDA approves new prostate cancer treatment from AstraZeneca and Merck This article rates 3.0 out of 5 stars

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