Zai Lab Limited (ZLAB) announced that China's National Medical Products Administration or NMPA has accepted the Biologics License Application or 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.
TIVDAK (tisotumab vedotin) is an antibody-drug conjugate (ADC) composed of Genmab's human monoclonal antibody directed to tissue factor (TF) and Pfizer's ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody.
TIVDAK received full approval from U.S. Food and Drug Administration in April 2024 for adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
Zai Lab has an exclusive license from Seagen Inc., acquired by Pfizer in 2023, to develop and commercialize TIVDAK in Greater China (mainland China, Hong Kong, Macau, and Taiwan, collectively).
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