Drugs

ODAC Recommends Deferring Action on Retifanlimab

Members of the Oncologic Drugs Advisory Committee voted 13-4 on 6/24 to recommend that FDA defer regulatory action on Incyte’s retifanlimab, pending more research. The company is seeking an indication to treat patients with locally advanced or metastatic squamous carcinoma of the anal canal who have progressed on or who are intolerant of platinum-based chemotherapy. Experts told Targeted Oncology that panel members felt that the 14% response rate in the POD1UM-202 study was too low to justify a regulatory decision at this time. No concerns were voiced about the drug’s safety, they said.

An FDA briefing paper had raised questions about retifanlimab’s safety and efficacy and asked the committee members to recommend whether it was appropriate to consider approving the drug at this time.

FDA has granted the retifanlimab BLA orphan drug and fast-track designations and priority review. The PDUFA action date is 7/25.

ODAC Recommends Deferring Action on Retifanlimab

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome