ImmunityBio Implements Enhanced Compliance Protocols Following FDA Warning Over Anktiva Marketing Claims

ImmunityBio has announced the implementation of comprehensive regulatory compliance measures following a warning letter from the Food and Drug Administration regarding promotional claims for Anktiva, its bladder cancer treatment. The FDA accused the company of making false or misleading statements about the therapeutic’s capabilities and approved uses.

The biotechnology firm stated it has introduced expanded promotional review protocols, executive training programmes and external regulatory oversight to ensure all promotional communications concerning Anktiva are accurate, balanced and compliant with FDA regulations. These measures followed an extensive review of all promotional materials and external communications conducted with the company’s legal and regulatory teams.

The company has removed a podcast episode identified by the regulator in its March warning letter from its corporate website and has requested its removal from all third-party platforms. The episode, entitled “Is the FDA BLOCKING Life Saving Cancer Treatments?”, featured an interview between Sean Spicer and ImmunityBio’s founder and chief scientific and medical officer Patrick Soon-Shiong.

The FDA’s warning letter took particular issue with statements made by Soon-Shiong during the January podcast. The regulator challenged claims that Anktiva could “actually treat all cancers” and could “prevent cancer if you were exposed to radiation”, despite the drug holding approval only for a specific type of bladder cancer. The FDA also objected to Soon-Shiong’s characterisation of Anktiva as “a single jab” administered subcutaneously, when the treatment is approved exclusively for intravesical use.

In its response to the regulator, ImmunityBio clarified that certain comments made by Soon-Shiong pertained to investigational applications of Anktiva’s IL-15 platform. The company characterised his statements as aspirational and forward-looking opinions regarding his vision for the drug development pipeline and the underlying scientific strategy for treating cancer patients.

The company confirmed on Monday that a television advertisement identified in the warning letter, which was previously available online, was never broadcast or disseminated to the public. According to the FDA, both the television advertisement and podcast episode contained misleading claims regarding the efficacy and directions for use of Anktiva, whilst minimising or omitting risk information and failing to list the drug’s full FDA-approved indication.

Richard Adcock, chief executive officer of ImmunityBio, stated the company takes promotional compliance with the utmost seriousness. He emphasised the firm’s dedication to maintaining a clear distinction between its investigational pipeline aspirations and the promoted indications for its approved therapies, expressing confidence that the substantive remedial actions and enhanced internal protocols address the agency’s concerns.

Anktiva received approval in 2024 for use alongside the Bacillus Calmette-Guérin vaccine to treat a specific subset of bladder cancer patients, namely those with BCG-unresponsive non-muscle-invasive bladder cancer with carcinoma in situ.