AstraZeneca PLC had hoped the Phase III PROpel trial would support a broad approval for first-line metastatic castration-resistant prostate cancer (mCRPC) for PARP inhibitor Lynparza (olaparib). But it found out on 1 June that the US Food and Drug Administration concurred with a 28 April advisory committee review that suggested a narrower indication limited to patients with BRCA-mutated tumors.
KEY TAKEAWAYS
- The FDA’s approval decision follows an advisory committee recommendation that the new indication be limited to patients with BRCA-mutated tumors, because that was the population that drove the PFS and OS benefits.
Lynparza, combined with Johnson & Johnson’s Zytiga (abiraterone) and prednisone or prednisolone, has EU approval for treatment of an...
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