LYNPARZA® (olaparib) Approved by FDA for Treatment of HRR Gene-Mutated Metastatic Castration-Resistant Prostate Cancer That Has Progressed Following Prior Treatment with Enzalutamide or Abiraterone
Only PARP Inhibitor to Improve Overall Survival vs. Enzalutamide or Abiraterone for Metastatic Castration-Resistant Prostate Cancer Patients with BRCA or ATM Mutations, A Key Secondary Endpoint in the Phase 3 PROfound Trial
Approximately 20-30% of Men with Metastatic Castration-Resistant Prostate Cancer Have an HRR Gene Mutation
KENILWORTH, N.J.–(BUSINESS WIRE)–AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved LYNPARZA for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Patients will be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA.
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