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Sandy Srinivas, MD


FDA Grants Priority Review to Olaparib-Based Combination for Metastatic Castration-Resistant Prostate Cancer

By: JNCCN 360 Staff
Posted: Tuesday, August 30, 2022

On August 16, AstraZeneca and Merck announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental new drug application for olaparib (Lynparza) in combination with abiraterone and prednisone or prednisolone for the treatment of adults with metastatic castration-resistant prostate cancer. The FDA has also granted Priority Review to this combination therapy in the United States. The FDA action date for its regulatory decision is anticipated during the fourth quarter of 2022.

Olaparib is a first-in-class PARP inhibitor and the first targeted treatment to block DNA damage response in cells or tumors harboring a deficiency in homologous recombination repair (HRR), such as those with mutations in BRCA1 and/or BRCA2. Olaparib has been approved in the United States for the treatment of patients with HRR gene–mutated metastatic castration-resistant prostate cancer who have experienced disease progression after prior treatment with enzalutamide or abiraterone.

The supplemental new drug application is based on results from the randomized phase III PROpel trial ( identifier NCT03732820), which included patients with metastatic castration-resistant prostate cancer who had not received prior chemotherapy or a new hormonal agent in this setting. These results showed that olaparib in combination with abiraterone reduced the risk of disease progression or death by 34% versus abiraterone alone (based on a hazard ratio of 0.66; 95% confidence interval = 0.54–0.81; P < .0001). The median radiographic progression-free survival was 24.8 months with the combination therapy versus 16.6 months with abiraterone alone. The safety and tolerability of olaparib in combination therapy with abiraterone were in line with those observed in prior clinical trials and the known profiles of the individual medicines.

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