FDA warns ImmunityBio over false cancer cure claims in podcast

The U.S. Food and Drug Administration (FDA) has issued a formal warning to ImmunityBio and its founder, Dr. Patrick Soon-Shiong. The agency criticised misleading claims about the cancer drug Anktiva made during a podcast. Regulators have now given the company 15 days to respond and correct the information. The FDA's warning centres on statements made by Dr. Soon-Shiong in a podcast where he suggested Anktiva could cure or prevent multiple types of cancer. The agency argued that these claims falsely imply the drug is a universal cancer cure. Additionally, the FDA noted that the podcast failed to mention potential risks and side effects associated with the treatment.

ImmunityBio has since removed the podcast link from its website. The company released a statement confirming it takes the FDA's concerns seriously and will work with regulators to address the issues raised. This action is part of a broader FDA crackdown on misleading public statements by drug manufacturers and online pharmacies. Over the past three years, the agency has targeted companies and individuals—including those promoting unapproved stem cell therapies and celebrities endorsing unauthorised COVID-19 treatments. Penalties in such cases have ranged from corrective advertising and product recalls to fines and halted promotions.

The FDA's warning requires ImmunityBio to submit a detailed response within 15 days. The company must clarify or retract the disputed claims about Anktiva. Failure to comply could lead to further regulatory action against the drug or its marketing.