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

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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 olaparib (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. 

Olaparib (Lynparza)

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 enzalutamide (Xtandi) or abiraterone (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
 

References

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

approves olaparib for HRR gene-mutated castration-resistant cancer. 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.

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:

Metastatic cancer

People with a genetic mutation linked to cancer risk

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IN-DEPTH REVIEW OF RESEARCH RELATED TO APPROVALS

()

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. 

Olaparib (Lynparza)

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

  • Progression-free survival was significantly longer for participants in the olaparib group (7.4 months) compared to the control group (3.6 months).
  • Time to pain progression was significantly longer in the olaparib group than the control group.
  • Overall survival was longer for patients in the olaparib 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 has guidelines on which men with  cancer should undergo genetic counseling and testing. Men with the following should speak with a genetics expert about genetic testing:

  • A tumor test result suggests an inherited mutation (for example, a  or  mutation in the tumor that may indicate an inherited mutation in one of those genes). 
  • A blood relative who tested positive for an inherited mutation in a gene linked to  cancer.
  • Metastic  cancer diagnosed at any age.
  • Intraductal/cribriform cells found on pathology.
  • Cancer that is categorized as very-high- or high-risk based on pathology.
  • Also diagnosed with male breast cancer.
  • Eastern European (Ashkenazi) Jewish ancestry. 
  • One or more first-, second-, or third-degree relatives diagnosed with breast cancer at age 50 or younger, or ovarian, pancreatic, male breast cancer,   cancer or intraductal/cribriform  cancer at any age.
  • two or more close relatives diagnosed with breast or  cancer at any age.

Updated: 12/14/2021

Expert Guidelines
Expert Guidelines

The National Comprehensive Cancer Network (NCCN) recommends tumor testing to help guide treatment in 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: 12/14/2021

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 inherited mutation
  • 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: 08/06/2022

Open Clinical Trials
Open Clinical Trials

The following are studies looking at treatment for people with advanced

Updated: 08/23/2022

Peer Support
Peer Support

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

Updated: 01/30/2022

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

How we rated the media

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