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 new drug for lung cancer had clinical trial data only from China; FDA officials made clear their opposition to using studies conducted in only one nation as a basis for drug approvals.