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FDA approves Lynparza to treat HRR gene-mutated metastatic castration-resistant prostate cancer. AstraZeneca + Merck Inc.,
AstraZeneca and MSD Inc.,have announced that Lynparza (olaparib) has been approved in the US for patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).
The approval by the FDA was based on results from the Phase III PROfound trial, which were published in The New England Journal of Medicine. 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.