FDA accepts Padcev and Keytruda sBLAs

The US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Applications (sBLAs) for Seagen (Nasdaq: SGEN) and Astellas’ (TYO: 4503) Padcev (enfortumab vedotin-ejfv) and Merck & Co’s (NYSE: MRK) Keytruda (pembrolizumab).

The sBLAs are for the use of these two agents in combination for the treatment of patients with locally advanced or metastatic urothelial cancer who are not eligible to receive cisplatin-containing chemotherapy. The applications are intended to expand both labels for Padcev and Keytruda.

"We look forward to working closely with the FDA as we seek potential accelerated approval for this combination"