A panel of independent advisers almost unanimously recommended to restrict a new indication for olaparib alongside abiraterone in patients with metastatic castration-resistant prostatecancer.
to patients whose tumors have a BRCA mutation. One member — Ravi A. Madan, MD, of the National Cancer Institute — abstained. The FDA staff asked panelists to abstain if they felt the combination treatment should not be approved for any indication.
Although the study met its primary endpoint, the results were difficult to interpret given the lack of information about genetic variability in the participants' tumors. Participants were not prospectively assessed for either BRCA or HRR status.
Madan also emphasized concerns the FDA raised about the potential harms for patients whose prostate cancer was not tied to BRCA mutations. In the FDA's briefing document, the agency said patients treated in the first-line metastatic castration-resistant prostate cancer setting generally have few symptoms at baseline. Adding olaparib among patients lacking the BRCA mutation could expose them to a drug with known side effects but minimal chance to help them.
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