FDA Drug Marketing Enforcement

The Food and Drug Administration has issued a formal warning letter to ImmunityBio, saying a TV commercial and a January episode of “The Sean Spicer Show” featuring executive chairman and chief medical officer Dr. Patrick Soon-Shiong make false or misleading claims about the company’s drug Anktiva. Regulators cite Soon-Shiong’s statements that the bladder‑cancer drug is “the most important molecule that could cure cancer,” that it “actually can treat all cancers,” and that it can prevent cancer after radiation exposure, even though Anktiva is approved only for a hard‑to‑treat form of bladder cancer and has not been cleared for other cancers or for prevention. The FDA says these promotions improperly suggest unapproved uses, falsely describe Anktiva as a “cancer vaccine,” and omit risk information such as urinary tract infections, pain, chills and fever, violating requirements to present a fair balance of benefits and risks. ImmunityBio shares fell more than 21% Tuesday after the letter was posted, the company quickly removed the podcast link from its website, and a spokesperson said it takes the warning “very seriously” and will work with the agency, which has given 15 days for a written response outlining corrective steps. The case highlights the FDA’s stepped‑up scrutiny under the Trump administration of drugmakers’ media appearances and online promotions, and raises broader questions about how far high‑profile executives can go in hyping experimental cancer treatments without running afoul of federal law.