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 continued use, and full approval, of Rubraca will require further verification of clinical benefit in the confirmatory Phase 3 TRITON3 trial (NCT02975934), which is still enrolling. Rubraca became the first PARP inhibitor approved for prostate cancer patients in the U.S., followed just five days later by Lynparza (olaparib), which received the FDA's nod for mCRPC patients with mutations in DNA repair genes. “Rubraca is the first in a class of drugs to become newly available to patients with mCRPC who harbor a deleterious BRCA mutation," Wassim Abida, MD, principal investigator in TRITON2, said in a press release. "Given the level and duration of responses observed with Rubraca in men with mCRPC and these mutations, it represents an important and timely new treatment option for this patient population." Rubraca, by Clovis Oncology, is an oral treatment that was initially approved for ovarian cancer. It works by blocking the activity of PARP enzymes, which are responsi
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