RTTNews | Jun 24, 2021 03:56PM EDT

15:55 Thursday, June 24, 2021 (RTTNews.com) - An FDA panel has recommended that regulatory decision on Incyte's (INCY) Retifanlimab injection should be delayed until more data are available.

Retifanlimab is proposed as a potential treatment of adult patients with locally advanced or metastatic squamous carcinoma of the anal canal (SCAC) who have progressed on or who are intolerant of platinum-based chemotherapy.

The Advisiory Committee voted 13-4 that a regulatory decision on retifanlimab should be deferred until further data are available from clinical trial POD1UM-303, a confirmatory trial in platinum-nave advanced SCAC that is currently underway.

Retifanlimab's Biologics License Application was reviewed by the Oncologic Drugs Advisory Committee of the FDA.

Squamous cell carcinoma of the anal canal, which accounts for nearly 3% of digestive system cancers, is associated with human papillomavirus (HPV) and HIV infections. Patients with advanced SCAC have a low 5-year survival rate, and there are currently no FDA-approved therapies for individuals who have progressed after first-line chemotherapy.

Although the FDA doesn't have to follow the advisory committee's recommendation, it often does.

"While we are disappointed by the outcome of today's ODAC vote, we will continue to work closely with the FDA as it completes its review of the BLA for retifanlimab," said Lance Leopold, Group Vice President, Immuno-Oncology Clinical Development, Incyte.

"Patients with advanced SCAC who have progressed after first-line platinum-based chemotherapy currently have no FDA-approved treatments available to them and face an extremely poor prognosis. We continue to believe that retifanlimab can provide an additional, much-needed option for these patients based on the favorable benefit/risk shown in our trial."

Read the original article on RTTNews ( https://www.rttnews.com/3204877/fda-panel-defers-incyte-s-anal-cancer-drug.aspx)

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