China’s NMPA Accepts BLA of Zai Lab’s Tivdak for Recurrent or Metastatic Cervical Cancer
Shots:
- China’s NMPA has accepted BLA of Tivdak for the treatment of recurrent or metastatic cervical cancer in pts who had disease progression on or after systemic therapy
- The BLA was supported by P-III (innovaTV 301) trial data, incl. clinical evidence from Chinese cohort, evaluating Tivdak vs CT in adults. Chinese pts had prior standard systemic therapies, with over 50% receiving anti-PD-L1 treatment
- In Chinese cohort, the trial showed a 45% reduced death risk, with favorable 2EPs (PFS & cORR). However, after 11.5mos. of mFU, mOS was not reached compared to 10.7mos.
Ref: PR Newswire | Image: Zai Lab
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