FDA committee favors restricting prostate cancer regimen to BRCA-positive subgroup

An FDA advisory committee recommended that a proposed indication for olaparib with abiraterone acetate as first-line treatment for metastatic castration-resistant prostate cancer be limited to patients whose tumors have BRCA mutations.
The Oncologic Drugs Advisory Committee voted 11 to 1 in favor of the restriction. One committee member abstained.
The FDA is not required to follow the advisory committee’s recommendation but often does so.
Olaparib (Lynparza; AstraZeneca, Merck) is a poly(ADP-ribose) polymerase (PARP) inhibitor. The agent is approved in the United States for treatment of

An FDA advisory committee recommended that a proposed indication for olaparib with abiraterone acetate as first-line treatment for metastatic castration-resistant prostate cancer be limited to patients whose tumors have BRCA mutations.
The Oncologic Drugs Advisory Committee voted 11 to 1 in favor of the restriction. One committee member abstained.
The FDA is not required to follow the advisory committee’s recommendation but often does so.
Olaparib (Lynparza; AstraZeneca, Merck) is a poly(ADP-ribose) polymerase (PARP) inhibitor. The agent is approved in the United States for treatment of