FDA Approves Lynparza (olaparib) Plus Abiraterone and Prednisone or Prednisolone for Treatment of Adult Patients With BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC)
AstraZeneca and Merck, known as MSD outside of the United States and Canada, has announced that Lynparza in combination with abiraterone and prednisone or prednisolone (abi/pred) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castrationresistant prostate cancer (mCRPC).
Patients should be selected for therapy based on an FDA-approved companion diagnostic for Lynparza. Results have shown significant improvement in rPFS for patients receiving Lynparza with abiraterone, compared to those receiving placebo with abiraterone, in the intent-to-treat (ITT) population. An exploratory subgroup analysis of 85 patients with BRCAm (11% of the population) showed a median rPFS that was not reached in the Lynparza with abiraterone group, compared to 8 months for the placebo with abiraterone group (hazard ratio [HR] 0.24). The OS hazard ratio in these patients was 0.30.
In the U.S., prostate cancer is the second most common cancer in men, and despite an increase in the number of available therapies for patients with mCRPC, five-year survival remains low. Many patients with mCRPC are only able to receive one line of therapy, as the disease can progress quickly.
Approximately 10% of patients with mCRPC will have BRCA mutations, which are associated with a poor prognosis and worse outcomes.
