FDA accelerated approval for Padcev with Keytruda in urothelial cancer

The US Food and Drug Administration (FDA) has granted accelerated approval of Padcev (enfortumab vedotin-ejfv) with Keytruda (pembrolizumab), with the decision coming ahead of anticipated date of April 21.

Under development by the USA’s Seagen (Nasdaq: SGEN) and Japan’s Astellas Pharma (TYO: 4503), the combination therapy is authorized for the treatment of adult patients with locally-advanced or metastatic urothelial cancer (la/mUC) who are not eligible to receive cisplatin-containing chemotherapy. Keytruda is Merck & Co’s (NYSE: MRK) blockbuster PD-1 inhibitor.

Continued approval for this indication is contingent upon verification and description of clinical benefit in the EV-302 confirmatory trial, noted Seagen, which is currently the subject of a $43 billion acquisition by US pharma giant Pfizer (NYSE: PFE).