May 31, 2023: Repotrectinib (Oral) / NSCLC / BMS: US FDA accepted priority review application
The approval is based on subgroup analysis of the Phase 3 PROpel trial evaluating Lynparza + Abiraterone and prednisone or prednisolone in patients with BRCA mutated mCRPC
Lynparza + abiraterone demonstrated highly clinically meaningful improvements in both radiographic progression-free survival and overall survival
Median rPFS and median OS were not reached for Lynparza + abiraterone vs the median of 8 months and 23 months respectively for abiraterone alone
Safety of the combination was in line with that observed in prior clinical trials
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