On April 28th, 2023, the FDA approved olaparib plus abiraterone acetate for first line treatment for metastatic castration-resistant prostate cancer, but only in patients whose tumors have BRCA mutations. Although a broad indication for the combination therapy was desired, concerns about the trial design were raised, and the phase III results did not explicitly show that patients without a BRCA mutation would benefit (1).
On August 11th, 2023, the FDA approved the use of niraparib and abiraterone acetate with prednisone in treating patients with BRCA-mutated castration-resistant prostate cancer. The green light comes backed by the robust efficacy data from the MAGNITUDE trial (2).
1U.S. Food and Drug Administration (FDA). FDA Briefing Document: NDA 208558/Supplement 25.
Available at www.fda.gov/media/167483/download. Social medica post June 16th, 2023.
Available at https://tinyurl.com/post6162023;
2Chi, et al. J Clin Oncol. 2023;41(18):3339-3351.
PMID: 36952634. Social medica post August 24th, 2023. Available at