Update: New drug combination for early treatment of some metastatic prostate cancer

Relevance: Medium-High

Research Timeline: Post Approval

Relevance Rating Details

What is this update about?

The FDA-approved Lynparza in combination with Zytiga (abiraterone) and prednisone (or prednisolone) as a treatment for metastatic castration-resistant prostate cancer for people with BRCA1 or BRCA2 mutation found on genetic testing or tumor testing.

This approval is based on the results of a large clinical trial called the PROpel trial. Prior to the study participants had received androgen deprivation therapy to treat mCRPC  but no other hormonal agents or chemotherapy. Participants were divided into two groups. All participants received Zytiga and prednisone. Half of the participants also received Lynparza and the other half received a sugar pill (placebo).

People who tested positive for a BRCA mutation responded especially well to Lynparza plus abiraterone compared to those who had placebo and abiraterone. After eight months, people with a BRCA1 or BRCA2  mutation who received Lynparza plus abiraterone were more likely to survive and less likely to have their cancer progress.

About Lynparza

Lynparza is a type of targeted therapy known as a PARP inhibitor. Like other PARP inhibitors, it can be effective against cancers with mutations in BRCA1 and BRCA2.

Lynparza (olaparib) is a pill. The most common side effects, in order of frequency, are:

• Low red blood cells (anemia)
• Fatigue 
• Nausea 
• Diarrhea 
• Decreased appetite
• Low white blood cells (Lymphopenia)
• Dizziness
• Stomach pain

In the clinical trial that led to this approval, almost 1 of 5 people taking Lynparza needed to receive at least one blood transfusion. One of 10  required more than one blood transfusion; however, they were still able to continue taking the drug.

What does this mean for me?

If you have metastatic castration-resistant prostate cancer (mCRPC), ask your doctor if Lynparza combined with Zytiga might be an option for you. Your doctor may recommend genetic counseling, genetic testing and tumor testing, or genetic testing for a BRCA mutation to see if you are eligible for Lynparza. If you have mCRPC and do not have a BRCA1 or BRCA2 you may still benefit from treatment with a PARP inhibitor.  You can find more information here.

Reference

FDA approves olaparib with abiraterone and prednisone (or prednisolone) for BRCA-mutated metastatic castration-resistant prostate cancer. FDA news release. May 31, 2023.

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.

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posted 9/11/23