Zai Lab’s Biologics Licence for TIVDAK Approved for Advanced Cervical Cancer Treatment
Thursday, March 13, 2025
Zai Lab has announced that China’s National Medical Products Administration (NMPA) has approved its Biologics Licence Application (BLA) for TIVDAK (tisotumab vedotin-tftv) for the treatment of patients with recurrent or metastatic cervical cancer who have experienced disease progression after systemic therapy.
Cervical cancer is a leading cause of cancer-related death among women in China, with a high number of new cases each year. Treatment options for recurrent or metastatic cervical cancer remain limited. TIVDAK has the potential to provide a new option for patients with advanced disease who have exhausted other treatments.
TIVDAK is an ADC that combines a monoclonal antibody targeting tissue factor (TF) with an anti-cancer agent. It is designed to bind to TF-expressing cancer cells, leading to internalisation of the drug and subsequent cell death. The treatment also engages immune system mechanisms to enhance its effect.
Cervical cancer remains a major health issue in China, with approximately 150,000 new cases diagnosed annually. Treatment options for patients with recurrent or metastatic disease after initial therapy are currently limited. TIVDAK, an antibody-drug conjugate (ADC), has shown promising results, including improved overall survival in the pivotal global Phase 3 innovaTV 301 trial.
The approval is supported by data from this clinical trial (NCT04697628), including results from a China-specific subpopulation. Findings from this group, reported in early 2025, were in line with the global trial results.
TIVDAK reduced the risk of death by 45% compared to chemotherapy (HR: 0.55 [95% CI: 0.27-1.15]) in patients who had received prior standard treatments, including anti-PD(L)1 therapy. At a median follow-up of 11.5 months, the median overall survival had not been reached in the TIVDAK group, compared to 10.7 months in the chemotherapy group.
Secondary outcomes, such as progression-free survival and objective response rate, also showed a benefit with TIVDAK. The safety profile in Chinese patients was consistent with global data.
Zai Lab holds an exclusive licence from Seagen Inc., which was acquired by Pfizer in 2023, to develop and commercialise TIVDAK in Greater China, including mainland China, Hong Kong, Macau, and Taiwan.
Source: zailaboratory.com
