Immunity Bio, Inc – FDA Warning Letter, Jan 19, 2026

The FDA"s Office of Prescription Drug Promotion issued a Warning Letter to ImmunityBio, Inc. on March 13, 2026, following a review of promotional communications for its drug Anktiva. The agency found a direct-to-consumer broadcast advertisement and a podcast, originally aired January 19, 2026, to be false or misleading. Key violations included misleading claims about Anktiva"s efficacy, suggesting it could cure or prevent all cancers, act as a single agent or vaccine, or be administered subcutaneously, despite being approved only for specific BCG-unresponsive nonmuscle invasive bladder cancer in combination with BCG, via intravesical use. The materials also lacked adequate directions for use for these unapproved indications and routes. Furthermore, the promotional content minimized or entirely omitted crucial risk information and failed to present the drug’s full FDA-approved indication. The company also failed to submit the podcast for FDA review as required by regulations. These actions misbrand Anktiva and violate the Federal Food, Drug, and Cosmetic Act, posing public health concerns by misrepresenting drug benefits to a vulnerable patient population. ImmunityBio is required to immediately cease the misleading promotions, provide a written response within 15 working days detailing a plan to discontinue such communications, and disseminate truthful, non-misleading corrective communications to the affected audience through the same media and frequency.