Dec 18, 2019: Seattle Genetics and Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval to PADCEV ™ for the treatment of adult patients with locally advanced or metastatic urothelial cancer for the patients who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery or also in a locally advanced or metastatic setting.
PADCEV (approved under the FDA’s Accelerated Approval Program ) is the first FDA approved treatment in the U.S. for these patients.
It is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein situated on the surface of cells and highly expressed in bladder cancer.
The FDA’s Accelerated Approval Program allows approval of a medicine that is based on a surrogate endpoint if the medicine fills an unmet medical need for the serious condition.
A global, randomized phase 3 confirmatory clinical trial (EV-301) is in progress and is also intended to support global registrations. https://www.oaoa.com/news/business/article_770940b8-3c8e-5154-9d92-40e44354226b.html
astellas.com/en/news/15511
