FDA Warns ImmunityBio on Anktiva Ad Claims

Federal health regulators issued a warning letter Tuesday to ImmunityBio Inc., criticizing a television advertisement and a podcast episode for making unsubstantiated claims about the biotechnology company's bladder cancer drug, Anktiva. The Food and Drug Administration cited statements from Executive Chairman and Chief Medical Officer Dr. Patrick Soon-Shiong that suggested the drug could treat, cure or prevent various cancers beyond its approved use, violating federal marketing rules.

The FDA's letter, addressed to ImmunityBio CEO Richard Adcock, focused on a January podcast appearance by Soon-Shiong on "The Sean Spicer Show," titled "Is the FDA Blocking Life-Saving Cancer Treatments?" During the episode, Soon-Shiong described Anktiva as "the most important molecule that could cure cancer" and claimed it could treat all cancers as well as prevent the disease in individuals exposed to radiation. The regulators determined these assertions created a misleading impression of the drug's efficacy, as Anktiva is approved only for adult patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors. The treatment requires...