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AstraZeneca’s Lynparza Adds Narrow Prostate Cancer Indication

FDA Follows Advisory Panel Recommendation On PARP Inhibitor

 
• By Joseph Haas

AstraZeneca had hoped data from Phase III PROpel would lead to an all-comers indication in first-line, metastatic castration-resistant prostate cancer, but new indication is limited to BRCA mutations.

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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