FDA grants regular approval and expands indication for Padcev

The US Food and Drug Administration has granted Padcev (enfortumab vedotin-ejfv) regular approval, in addition to approving a new indication for adult patients with locally-advanced or metastatic urothelial cancer who are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.

Padcev is marketed in the USA by Seagen (Nasdaq: SGEN) under a partnership with Japan’s Astellas Pharma (TYO: 4503).

In 2019, the FDA granted accelerated approval for 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 urothelial cancer setting. The conversion from accelerated approval to regular approval and the label expansion were based on two supplemental Biologics License Applications (sBLAs) reviewed under the Real-Time Oncology Review (RTOR) pilot program.