KENILWORTH - 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.

The approval was based on positive results from Phase 3 PROfound trial and published in The New England Journal of Medicine on April 28, 2020.

Prostate cancer is the second-most common cancer in men, and despite an increase in the number of available therapies for men with mCRPC, five-year survival remains low. HRR gene mutations occur in approximately 20-30% of patients with mCRPC.

Dr. Maha Hussain, one of the principal investigators of the PROfound trial and deputy director of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, said, 'Prostate cancer has lagged behind other solid tumors in the era of precision medicine. I am thrilled by the approval of LYNPARZA, which now brings a molecularly targeted treatment for this patient population in the U.S. The PROfound trial was an international effort and I want to thank the patients, their families, the investigators and their teams involved in making it possible.'

Results from the PROfound trial showed LYNPARZA reduced the risk of disease progression or death by 66% (HR 0.34 [95% CI, 0.25-0.47], p

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