FDA Approves Lynparza for mCRPC Patients with Mutations in DNA Repair Genes

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FDA Approves Lynparza for mCRPC Patients with Mutations in DNA Repair Genes
May 23, 2020May 23, 2020
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The U.S. Food and Drug Administration has approved the oral therapy Lynparza (olaparib) for treating men with metastatic castration-resistant prostate cancer (mCRPC) who carry mutations in homologous recombination repair (HRR) genes, including BRCA or ATM. Approval is specific for men who failed prior treatment with Xtandi (enzalutamid) or Zytiga (abiraterone acetate), two hormone therapies. The decision was based on findings from the Phase 3 PROfound trial (NCT02987543), in which Lynparza significantly extended survival and the time without disease worsening or…

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