FDA accepted, for priority review, supplemental Biologics License Applications for Padcev (enfortumab vedotin-ejfv) and Keytruda (pembrolizumab) for 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.
ImmunityBio and its owner and executive chairman Patrick Soon-Shiong received a warning letter from FDA for making false and misleading claims about a cancer treatment in television ads and on a podcast.
