China's National Medical Products Administration OKs PADCEV-KEYTRUDA combo for Bladder Cancer

 - First regimen to be approved in China to demonstrate superiority to platinum-containing chemotherapy for the treatment of locally advanced or metastatic urothelial cancer, the standard of care for nearly 40 years1

- NMPA approval based on the global Phase 3 EV-302 trial (also known as KEYNOTE-A39) where the treatment combination significantly improved overall survival and progression-free survival outcomes1

Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, "Astellas") today announced that China's National Medical Products Administration (NMPA) has approved PADCEV™ (enfortumab vedotin) in combination with KEYTRUDA® (pembrolizumab) for adult patients with locally advanced or metastatic urothelial cancer (la/mUC). The treatment combination will provide a new therapeutic option to patients with la/mUC in China and offer an alternative to platinum-containing chemotherapy, the standard of care for nearly 40 years.

https://www.prnewswire.com/news-releases/chinas-national-medical-products-administration-nmpa-approves-padcev-in-combination-with-keytruda-pembrolizumab-for-the-treatment-of-advanced-bladder-cancer-302345641.html