FDA Extends Review Period For AstraZeneca-Merck Partnered Cancer Drug, Lynparza

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.
Photo Via Company