Drugs

FDA Priority Review for Lynparza sNDA

FDA has accepted for priority review an AstraZeneca supplemental NDA for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone for treating adult patients with metastatic castration-resistant prostate cancer (mCRPC).

The submission is based on data from the PROpel Phase 3 trial that showed Lynparza in combination with abiraterone reduced the risk of disease progression or death by 34% versus abiraterone alone, according to the company. “The safety and tolerability of Lynparza in combination with abiraterone was in line with that observed in prior clinical trials and the known profiles of the individual medicines,” it says.

Lynparza is currently approved for patients with homologous recombination repair (HRR) gene-mutated mCRPC (BRCA-mutated and other HRR gene mutations) who have progressed following prior treatment with enzalutamide or abiraterone.

FDA Priority Review for Lynparza sNDA

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