Astellas' Nectin-4 ADC Padcev Gains China Approval for Metastatic Urothelial Cancer

▎Armstrong

On August 19, 2024, Astellas' Nectin-4 ADC new drug, Vedotin, was approved for marketing by the NMPA.For the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have previously received PD-1/PD-L1 inhibitors and platinum-based chemotherapy.

In the first half of 2024, Padcev's global sales reached $833 million, and it is expected to surpass Adcetris this year to become the third best-selling ADC drug, only behind Enhertu and Kadcyla.

In March this year, Astellas also submitted a new indication application in China.In combination with Keytruda for the first-line treatment of adult patients with previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC).

Summary

In China, Mabwell’s Nectin-4 ADC new drug 9MW2821 has been the first to enter Phase III clinical trials. Its platinum-based chemotherapy and PD-(L)1 subsequent-line treatment for urothelial carcinoma have successively received Breakthrough Therapy Designation in both China and the United States. In addition, active clinical research is being conducted on various types of cancers, including esophageal cancer, cervical cancer, and triple-negative breast cancer.