The FDA issued a warning letter to ImmunityBio over “false and misleading” claims made in a TV advertisement and a podcast about Anktiva, the company’s bladder cancer treatment marketed as requiring combination use with a vaccine. The agency said the content gave a misleading impression that Anktiva can cure or prevent all cancers. In the letter, FDA faulted multiple material omissions, including that Anktiva must be used with a vaccine and that risks were downplayed or not mentioned. The FDA also said the ads and podcast suggested patients treated with Anktiva would be “cancer free,” which it said was not supported by clinical studies. The warning letter followed content attributed to Patrick Soon-Shiong, who is closely tied to ImmunityBio and has faced controversy in biotech communications. For regulators and sponsors, the issue underscores how marketing claims can create compliance exposure independent of trial outcomes. In practical terms, the FDA action increases pressure on immuno-oncology companies to align promotional messaging with approved labeling and to tighten review of multimedia claims that can spread faster than traditional materials.