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

FDA Approves Lynparza for mCRPC Patients with Mutations in DNA Repair Genes
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 (enzalutamide) 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 death, compared with these hormone therapies. "Today marks the first approval for Lynparza in prostate cancer," Dave Fredrickson, executive vice president of the Oncology Business Unit at AstraZeneca, said in a press release. "In the PROfound trial, Lynparza more than doubled median radiographic progression-free survival and is the only PARP inhibitor to improve overall survival, versus enzalutamide or abiraterone for men with BRCA or ATM mutations." Lynparza, developed by AstraZeneca and Merck (known as MSD outside the U.S. and Canada), is a type of treatment called a PARP inhibitor and has also been approved to treat advanced cancers of the ovary, breast, and pancreas. It works by inhibiting the PARP enzyme — a DNA damage sensor — leading to the accumulation of DNA damage and ultimately the death of cancer cells. PROfound is comparing the safety and efficacy of Lynparza with that of Xtandi or Zytiga across 387 mCRPC patients whose disease progressed while on these hormone therapies. PARP inhibitors are particularly effective in cancer cells carrying defects in other DNA repair pathways — because they need PARP to survive and grow. In the PROfound trial, researchers examined Ly
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