- The FDA will extend the Prescription Drug User Fee Act (PDUFA) date for AstraZeneca Plc AZN and Merck & Co Inc's MRK supplemental marketing application for Lynparza (olaparib) by three months.
- The application seeks approval for Lynparza in combination with abiraterone & prednisone or prednisolone for metastatic castration-resistant prostate cancer (mCRPC).
- Related: AstraZeneca-Merck's Lynparza Treatment Shows Long-Term Survival In Ovarian Cancer.
- The supplemental application is based on the pivotal PROpel Phase 3 trial.
- In November, the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of Lynparza + abiraterone + prednisone or prednisolone for mCRPC patients for whom chemotherapy is not clinically indicated. This combination is also undergoing regulatory reviews in other countries.
- Lynparza is approved in the U.S. based on results from the PROfound Phase 3 trial as monotherapy for patients with homologous recombination repair (HRR) gene-mutated mCRPC (BRCA-mutated and other HRR gene mutations) who have progressed following prior treatment.
- Price Action: AZN shares are down 0.20% at $70.30 during the premarket session on the last check Thursday.
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