By Adriano Marchese
ImmunityBio is seeking an urgent meeting with U.S. health regulators after its bladder-cancer treatment application was rejected.
The immunotherapy company said Monday that it received a refusal-to-file letter from the Food and Drug Administration regarding ImmunityBio's supplemental biologics license application for use of Anktiva.
The San Diego company said the letter came despite the regulator's unanimous guidance and encouragement at an in-person January meeting for ImmunityBio to submit the application.
"At this meeting all key decision makers were specifically asked and unanimously confirmed that ImmunityBio should submit the sBLA as soon as possible based on the data in the single-arm trial," the company said.
The drug is designed to be used alongside Bacillus Calmette-Guerin, a common bladder-cancer treatment, specifically for patients with papillary disease whose cancer hasn't responded to the BCG treatment alone.
The company said that it had made the decision to submit the license application in March based on the positive feedback it received from its meeting in January.
It has now requested an urgent meeting with the FDA to clarify the situation.
Shares were 8.3% lower in premarket trading at $2.33.
Write to Adriano Marchese at adriano.marchese@wsj.com
(END) Dow Jones Newswires
May 05, 2025 07:23 ET (11:23 GMT)
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