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The FDA has approved olaparib for the treatment of patients with metastatic castration-resistant prostate cancer who have deleterious or suspected deleterious germline or somatic HRR gene mutations and have progressed following prior treatment with a new hormonal agent.

The FDA has accepted and granted a priority review to a supplemental Biologics License Application for pembrolizumab for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors with tissue tumor mutational burden-high who have progressed following prior treatment and who have no satisfactory alternative treatment options.