FDA warns ImmunityBio over false cancer drug cure claims in podcast

The US Food and Drug Administration (FDA) has issued a warning to ImmunityBio and its founder, Dr. Patrick Soon-Shiong, over misleading claims about the cancer drug Anktiva. The regulator flagged statements made in a podcast where the drug was described as a potential cure for multiple cancers beyond its approved use. ImmunityBio now has 15 days to respond and correct the violations.

The controversy began when Dr. Soon-Shiong discussed Anktiva in a podcast, suggesting it could cure or prevent various cancers. The FDA deemed these claims false and in breach of drug advertising rules, as Anktiva is currently only approved for bladder cancer. The agency also noted that the podcast failed to mention risks like urinary tract infections and fever.

ImmunityBio has since removed the podcast from its website. The company stated it takes the warning seriously and will cooperate with regulators to resolve the issue. This is not the first time the FDA has taken action against exaggerated health claims. In 2019, Celsius Holdings received a warning for unproven weight loss claims, while Beam Therapeutics was reprimanded in 2021 for promoting unapproved gene therapies on social media. Under the Trump administration, the FDA stepped up enforcement against misleading public statements by drugmakers.

The FDA's warning gives ImmunityBio a 15-day deadline to address the violations. Failure to comply could lead to further penalties, including product seizures or legal action. The case highlights the regulator's ongoing scrutiny of public claims made by pharmaceutical companies and their representatives.