Lynparza Approved for Prostate Cancer

The FDA has approved AstraZeneca’s and Merck’s Lynparza for treatment of patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).

The approval was based on the results of a phase 3 trial, which showed that Lynparza (olaparib) reduced disease progression or death by 66 percent. It also extended progression-free survival to a median of 7.4 months vs. 3.6 months for patients treated with enzalutamide or abiraterone.

HRR gene mutations occur in approximately 20 percent to 30 percent of patients with mCRPC.