Rubraca Receives Conditional FDA Approval for metastatic CRPC Patients with BRCA Mutations

Rubraca Receives Conditional FDA Approval for metastatic CRPC Patients with BRCA Mutations
The U.S. Food and Drug Administration (FDA) has granted conditional approval to Rubraca (rucaparib) for treating patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA mutations who have previously received an androgen receptor inhibitor and taxane-based chemotherapy. The agency's decision was made under an accelerated approval process after previously granting the therapy breakthrough therapy designation and priority review status for the same indication. It was based on promising response rates and duration of responses seen in patients receiving the therapy in the Phase 2 TRITON2 trial (NCT02952534). Accelerated approval is given to a medication that addresses an unmet need in a serious medical condition, providing it has shown benefits in a clinical trial. The con
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