FDA Grants Accelerated Approval to Astellas

The U.S. Food and Drug Administration 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 who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery or in a locally advanced or metastatic setting.

PADCEV is approved under the FDA’s Accelerated Approval Program based on tumor response rate.

Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

Read Seattle Genetics’ and Astellas’s press release here.