Chinese biotech Zai Lab Limited (ZLAB) announced late Monday that Chinese regulators approved its antibody-drug conjugate Tivdak, developed with Pfizer (PFE) and Genmab (GMAB), as a late-line treatment for adults with cervical cancer.
Specifically, China’s National Medical Products Administration has cleared the Biologics License Application for Tivdak, targeted at adults with recurrent or metastatic cervical cancer who have previously undergone chemotherapy.
The decision is supported by data from a global Phase 3 trial called innovaTV 301, which indicated that the injectable led to a benefit in overall survival compared to chemotherapy in the targeted patient population, including a subset of Chinese patients.
An estimated 150K patients are diagnosed with cervical cancer in China each year, with those having the recurrent or metastatic forms of the disease having to deal with the cancer progression due to limited treatment options.
In 2022, Zai Lab (ZLAB) received exclusive licensing rights to develop and commercialize Tivdak in mainland China, Hong Kong, Macau, and Taiwan as part of an agreement with Seagen, which Pfizer (PFE) acquired in 2023 for $43B.
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