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.
George F. Tidmarsh has resigned from his job as director of the FDA Center for Drug Evaluation and Research in the aftermath of a lawsuit by a former associate and a probe into what an HHS spokesperson described as “serious concerns about his personal conduct.”
