July 23 Quick Takes: FDA wants more data from Incyte on retifanlimab

Incyte Corp. (NASDAQ:INCY) may have to wait on results from the confirmatory POD1UM-303 study of retifanlimab before FDA will approve the intravenous PD-1 inhibitor for locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) who have progressed after chemotherapy. A complete response letter had been expected after FDA’s Oncologic Drugs Advisory Committee voted on June 24 to recommend that a regulatory decision be deferred until further data are available. The company will meet with the agency to discuss next steps.

FDA approved Dalvance dalbavancin from AbbVie Inc. (NYSE:ABBV) to treat acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients from birth. Also gaining approval for use in children, Bydureon BCise exenatide extended-release from  AstraZeneca plc (LSE:AZN; NASDAQ:AZN) is now approved to treat Type II diabetes in patients 10 to 17 years...