Zai Lab secures China NMPA approval for TIVDAK to treat cervical cancer
Zai Lab Limited secured China NMPA approval for TIVDAK to treat recurrent or metastatic cervical cancer, based on Phase 3 trial data showing overall survival benefit. The therapy is the first antibody-drug conjugate approved for this indication in China, addressing a significant unmet need for patients with limited treatment options.
*this image is generated using AI for illustrative purposes only.
Zai Lab Limited announced that China's National Medical Products Administration (NMPA) has approved the Biologics License Application (BLA) for TIVDAK (tisotumab vedotin for injection) for the treatment of adult patients with recurrent or metastatic cervical cancer. This approval marks the first time an antibody-drug conjugate (ADC) is available in China for previously treated recurrent or metastatic cervical cancer. The regulatory decision is based on results from the global, randomized, Phase 3 innovaTV 301 clinical trial, which met its primary endpoint of overall survival (OS) benefit compared to chemotherapy.
The approval follows previous regulatory clearances in the United States, Japan, European Union, United Kingdom, Macau (China), and Hong Kong (China). Zai Lab holds an exclusive license from Seagen Inc., acquired by Pfizer, for TIVDAK in Greater China, encompassing mainland China, Hong Kong, Macau, and Taiwan. The company is responsible for the development, supply, and commercialization of the therapy in the region.
Clinical Trial Data
The Phase 3 innovaTV 301 trial included a China subpopulation conducted by Zai Lab. In the global intention-to-treat (ITT) population, the trial met its primary endpoint with a hazard ratio (HR) of 0.70 (95% CI: 0.54–0.89; two-sided p=0.0038). The China subpopulation showed consistent results, demonstrating a clinically meaningful improvement in OS with an HR of 0.55 (95% CI: 0.27-1.15), corresponding to a 45% reduction in the risk of death compared to chemotherapy.
Safety and Efficacy
Safety data from the China subpopulation showed no new signals. The most common Grade ≥3 treatment-emergent adverse events (TEAEs) in the China subpopulation were anemia (11.4%), cough (5.7%), and malaise (5.7%). In the global study, the most common Grade ≥3 TEAEs were anemia (8.4%), urinary tract infection (4.4%), and abdominal pain (4.0%).
| Metric | Global Study | China Subpopulation |
|---|---|---|
| Primary Endpoint (OS) | HR=0.70; 95% CI: 0.54–0.89; p=0.0038 | HR=0.55; 95% CI: 0.27-1.15 |
| Risk of Death Reduction | Not specified | 45% |
| Prior anti-PD(L)1 Therapy | Not specified | 54.1% |
| Common Grade ≥3 TEAEs | Anemia (8.4%), UTI (4.4%), Abdominal pain (4.0%) | Anemia (11.4%), Cough (5.7%), Malaise (5.7%) |
Strategic Commercialization
Zai Lab plans to leverage its experience in the Chinese gynecologic oncology community and commercial synergies with its ZEJULA team to launch TIVDAK. Cervical cancer remains a leading cause of cancer death in women in China, with an estimated 150,000 new cases occurring annually. Treatment options are limited for patients with recurrent or metastatic disease who have progressed on or after chemotherapy.
Rafael G. Amado, M.D., President and Head of Global Research and Development at Zai Lab, emphasized the significance of the approval, stating that antibody-drug conjugates offer a novel and effective treatment class. Dr. Lingying Wu, Ph.D., China Leading Principal Investigator of the innovaTV 301 Study, noted that the China subpopulation data demonstrate significant clinical benefits irrespective of prior PD-(L)1 inhibitor therapy.
What is the anticipated pricing strategy for TIVDAK in China given the high unmet medical need and local market dynamics?
How will Zai Lab leverage its existing commercial infrastructure for ZEJULA to maximize market penetration for TIVDAK?
What are the potential challenges for reimbursement inclusion by the National Healthcare Security Administration (NHSA) for this novel therapy?
20
Access 50+ Readymade Screeners 
Use 200+ Custom Filters 
Get Full Market Insights 
