Weekly Digest - 27 May-02 Jun 2023

Weekly Digest - 27 May-02 Jun 2023

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

  • Lynparza is already approved in the US as monotherapy for patients with homologous recombination repair (HRR) gene-mutated mCRPC

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