Weekly Digest - March 2025

Weekly Digest - March 2025

12 Mar 2025: Zai Lab announces acceptance of biologics license application for TIVDAK for the treatment of patients with recurrent or metastatic Cervical cancer

  • Zai Lab announced that China’s NMPA has accepted the BLA for TIVDAK to treat advanced cervical cancer following systemic therapy
  • The global innovaTV 301 trial demonstrated that TIVDAK significantly improved overall survival, reducing the risk of death by 45% compared to chemotherapy
  • The median overall survival was not reached with TIVDAK, while it was 7 months for chemotherapy. Other key endpoints, including PFS and ORR, also favored TIVDAK
  • The BLA submission is based on Phase 3 trial innovaTV 301, including data from a China-specific subpopulation

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