Zai Lab Limited announced that China’s National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for TIVDAK (tisotumab vedotin-tftv) for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy.

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“In China, cervical cancer is a serious health concern with approximately 150,000 new cases diagnosed annually’

“In China, cervical cancer is a serious health concern with approximately 150,000 new cases diagnosed annually,” said Dr. Rafael Amado, M.D., President, Head of Global Research and Development at Zai Lab. “Treatment options for patients experiencing recurrence or metastasis after initial treatment are limited. TIVDAK, the only antibody-drug conjugate (ADC) therapy in cervical cancer, demonstrated promising benefits including a clinically meaningful improvement in overall survival (OS) in the pivotal global innovaTV 301 trial. If approved, TIVDAK will leverage our existing commercial infrastructure for ZEJULA, expanding our ability to offer treatment for women‘s cancer.”

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The BLA submission is supported by the results from the global, randomized, Phase 3 innovaTV 301 clinical trial and the results from the China subpopulation of this study. As reported in January 2025, the China subpopulation results were consistent with those in the global population:

  • TIVDAK demonstrated a 45% reduction in the risk of death compared to chemotherapy (HR: 0.55 [95% CI: 0.27-1.15] in the China subpopulation who had received prior standard systemic therapies, with more than half of this Chinese population having received prior anti-PD(L)1 therapy. After a median follow-up of 11.5 months, the median OS was not reached in the TIVDAK arm versus 10.7 months in the chemotherapy arm.
  • Secondary endpoints of progression-free survival (PFS) and confirmed objective response rate (ORR) also favored treatment with TIVDAK.
  • The safety of TIVDAK in the China subpopulation was manageable and consistent with the global profile.

About Cervical Cancer in China

Cervical cancer remains one of the leading causes of cancer death in women in China. An estimated 150,000 new cases of cervical cancer occur annually in China. Current treatment options are limited for patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy. TIVDAK is well positioned to provide a new option for previously treated advanced cervical cancer patients who currently have limited treatment options and poor outcomes.

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Source – businesswire