Biotech Billionaire Gets FDA Warning Over Cancer Drug Claims

Federal regulators issued a warning to biotech billionaire Dr. Patrick Soon-Shiong after he made misleading claims about his company's cancer drug on a podcast. The FDA said his statements about the bladder cancer medication being able to cure or prevent all cancers violated federal marketing rules.

Federal health regulators issued a warning Tuesday to biotech billionaire Dr. Patrick Soon-Shiong after he made misleading public statements about his company’s cancer treatment capabilities.

The Food and Drug Administration’s warning letter targets statements Soon-Shiong made on a podcast where he claimed his company’s bladder cancer medication could potentially treat, cure, or prevent various other cancer types.

The regulatory action focuses on promotional content for Anktiva, the primary product from ImmunityBio Inc., one of multiple biotech companies owned by Soon-Shiong, who also controls the Los Angeles Times newspaper.

Following the FDA’s public warning, ImmunityBio’s stock price dropped more than 24% during Tuesday’s trading session.

Federal approval for Anktiva came in 2024, specifically for treating a challenging form of bladder cancer. ImmunityBio continues seeking regulatory approval to use the medication for additional conditions, including certain lung and pancreatic cancers.

The problematic remarks occurred during a January broadcast of The Sean Spicer Show podcast, which carried the title “Is the FDA blocking life-saving cancer treatments?”

During the interview, Soon-Shiong called his company’s medication “the most important molecule that could cure cancer.” The executive chairman and chief medical officer later stated that although regulatory approval covers bladder cancer, “it actually can treat all cancers.”

He also claimed during the episode: “We have the therapy to prevent cancer if you were exposed to radiation, and that’s Anktiva.”

FDA officials determined these statements breach federal drug marketing regulations by generating “a misleading impression” about the medication’s capabilities.

Regulators additionally noted the podcast failed to include required information about potential risks and adverse effects, which may include urinary tract infections, pain, chills and fever. Federal law mandates that drug promotional materials present balanced information about both benefits and risks.

The FDA warning, directed to ImmunityBio CEO Richard Adcock, raises comparable issues with a television commercial for Anktiva. Both the advertisement and podcast incorrectly label the company’s treatment as a “cancer vaccine,” according to regulators.

The agency has given the company 15 days to address these violations and provide written plans for correction. By Tuesday afternoon, the podcast link had been taken down from ImmunityBio’s website.

Sarah Singleton, a spokesperson for the Culver City, California-based company, stated in an email that ImmunityBio considers the FDA’s warning “very seriously” and intends to “work cooperatively with the agency to address the matters raised in the letter.”

The Trump administration’s FDA has increased enforcement actions against pharmaceutical companies and online pharmacies, including oversight of executive appearances on television programs and podcasts.