In response to a warning letter from the FDA that accused the company of making “false or misleading” claims about its bladder cancer drug Anktiva, ImmunityBio is implementing enhanced measures aimed at ensuring that all promotional communications relating to the drug are “accurate, balanced and compliant with FDA regulations,” the company said in a release.
Among the measures ImmunityBio has implemented are “expanded promotional review protocols,” executive training and external regulatory oversight, the company said. The moves follow a “comprehensive review of all promotional materials and external communications” with its legal and regulatory teams, ImmunityBio explained.
ImmunityBio added that it has removed from its corporate website a podcast identified by the U.S. regulator in its March warning letter. The company has also requested the removal of the podcast from all third-party platforms, it said.
The episode—titled “Is the FDA BLOCKING Life Saving Cancer Treatments?”—was still available on Monday afternoon among those listed for the Sean Spicer Show. In the Jan. 19 podcast, Spicer interviewed ImmunityBio’s high-profile founder and chief scientific and medical officer, Patrick Soon-Shiong, M.D.
In the warning letter last month, the FDA took issue with Soon-Shiong’s claims that Anktiva “actually can treat all cancers” and can “prevent cancer if you were exposed to radiation,” despite the drug’s approval only in one type of bladder cancer.
The FDA also cited Soon-Shiong’s characterization of Anktiva as “a single jab” and a “little vial that you inject subcutaneously,” though the treatment is approved only for intravesical use.
In its response to the FDA, ImmunityBio clarified that some of Soon-Shiong’s comments were focused on the “investigational applications” of Anktiva’s IL-15 platform. In general, Soon-Shiong’s comments were “aspirational and forward-looking opinions regarding his vision for the company’s drug development pipeline and the underlying science supporting the strategy of treating patients with cancer,” the biotech explained.
Additionally, ImmunityBio on Monday confirmed that an advertisement produced for television, which was identified in the warning letter and was once available online, was never broadcast or “disseminated to the public.”
According to the FDA’s letter, both the TV ad and podcast episode contained misleading claims about the efficacy and directions for use of Anktiva while minimizing or omitting its risk information and failing to list the drug’s full FDA-approved indication.
“ImmunityBio takes promotional compliance with the utmost seriousness,” ImmunityBio CEO Richard Adcock said in the release. “We are dedicated to maintaining a clear distinction between our investigational pipeline aspirations and the promoted indications for our approved therapies. We believe our substantive remedial actions and enhanced internal protocols address the agency’s concerns.”
Anktiva was approved alongside the Bacillus Calmette-Guérin (BCG) vaccine in 2024 to treat a small subset of bladder cancer patients—those with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS).