Seattle Genetics PADCEV nabs 1st-line bladder cancer accelerated review

Seattle Genetics (NASDAQ:SGEN) and collaboration partner Astellas Pharma (OTCPK:ALPMF) announce Breakthrough Therapy status in the U.S. for antibody-drug conjugate PADCEV (enfortumab vedotin-ejfv), combined with Merck’s (NYSE:MRK) Keytruda (pembrolizumab), for the treatment of patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in a first-line setting.

Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.

The FDA approved PADCEV in December 2019 for urothelial cancer patients who have previously received a PD-1/L1 inhibitor and platinum-based chemo before or after surgery.

https://seekingalpha.com/news/3543233-seattle-genetics-padcev-nabs-accelerated-review-for-first-line-bladder-cancer