China’s NMPA approves TIVDAK® (tisotumab vedotin), the first antibody-drug conjugate for recurrent or metastatic cervical cancer after chemotherapy, supported by Phase 3 survival data.
Written By: Meghana Jinka, PharmD
Reviewed By: Pharmacally Editorial Team
China’s National Medical Products Administration (NMPA) has approved TIVDAK® (tisotumab vedotin) for adults with recurrent or metastatic cervical cancer whose disease has progressed following chemotherapy. The decision introduces the first antibody-drug conjugate (ADC) for advanced cervical cancer in China and expands treatment options for patients with limited alternatives after standard therapy.
Disease Burden
Cervical cancer remains a major public health challenge in China, with approximately 150,000 new cases diagnosed each year. Outcomes remain poor for patients whose disease recurs or metastasizes after systemic treatment, underscoring the need for new therapeutic approaches beyond chemotherapy and immunotherapy.
Clinical Evidence
The approval was supported by the pivotal Phase 3 innovaTV 301 trials (NCT04697628), which met its primary endpoint of overall survival (OS). In the global study, TIVDAK reduced the risk of death by 30% compared with investigator’s choice chemotherapy (HR 0.70; 95% CI, 0.54–0.89; p=0.0038).
Results from the China subgroup were consistent with the global findings. TIVDAK reduced the risk of death by 45% versus chemotherapy (HR 0.55; 95% CI, 0.27–1.15), demonstrating clinically meaningful benefit in Chinese patients.
54.1% of patients in the China subgroup had previously received PD-(L)1 inhibitors, which are now widely used in advanced cervical cancer. TIVDAK maintained a consistent overall survival benefit trend regardless of prior immunotherapy exposure, supporting its role within the evolving treatment landscape.
Safety Profile
The safety profile was consistent with previous studies, and no new safety signals were identified. In the global trial, the most common grade 3 or higher treatment-emergent adverse events (TEAEs) were anemia (8.4%), urinary tract infection (4.4%), and abdominal pain (4.0%).
Among Chinese patients, the most frequently reported grade 3 or higher TEAEs were anemia (11.4%), cough (5.7%), and malaise (5.7%).
Mechanism of Action
TIVDAK is an ADC directed against tissue factor (TF), a protein frequently expressed on cervical cancer cells. After binding to TF-expressing tumor cells, the ADC is internalized and releases the cytotoxic payload monomethyl auristatin E (MMAE), leading to cell cycle arrest and apoptotic cell death.
Preclinical studies also suggest immune-mediated antitumor activity through antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis, providing additional mechanisms that may contribute to its anticancer effects.
Commercialization Impact
The approval adds China to a growing list of markets where TIVDAK is available, including the United States, European Union, United Kingdom, Japan, Hong Kong, and Macau.
Zai Lab holds exclusive rights to develop, supply, and commercialize TIVDAK across Greater China under a licensing agreement originally established with Seagen, now part of Pfizer. The company will commercialize the therapy through its existing gynecologic oncology network, building on experience gained from ZEJULA®.
Clinical Implications
“This approval delivers a new treatment class to women in China with advanced cervical cancer,” said Rafael G. Amado, M.D., President and Head of Global Research and Development at Zai Lab. He noted that the decision further validates the global clinical evidence supporting TIVDAK in patients with recurrent or metastatic disease who have limited treatment options.
Lingying Wu, M.D., Ph.D., China lead principal investigator for innovaTV 301 and Professor of Gynecologic Oncology at the National Cancer Center and Cancer Hospital of the Chinese Academy of Medical Sciences, said the China subgroup analysis mirrored the global findings and demonstrated clinically meaningful benefit regardless of prior PD-(L)1 inhibitor therapy.
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About the Writer
Meghana Jinka (LinkedIn) is a Pharm.D graduate with a strong interest in clinical pharmacy, clinical research, pharmacovigilance, and medical writing. She has developed expertise in evaluating scientific literature, interpreting clinical data, and communicating complex medical information in a clear and accessible manner. Through clinical training, patient counseling, and healthcare awareness activities, she has gained practical experience in evidence-based medicine and patient-centered care. Passionate about healthcare communication, Meghana is committed to developing accurate, engaging, and evidence-based healthcare documents that support healthcare professionals and the wider community.