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
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