FDA Grants Accelerated Approval to Astellas’ and Seattle Genetics’ PADCEV

December 19, 2019

Yesterday, 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.

For more information about PADCEV, please click here.  For prescribing information including full safety information, please visit this link.

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