Washington — The Food and Drug Administration (FDA) has issued a warning regarding misleading assertions made by Dr. Patrick Soon-Shiong, a prominent figure in the biotech sector, concerning the bladder cancer drug Anktiva. Recently, in a podcast appearance, Dr. Soon-Shiong claimed that Anktiva could potentially treat, cure, or even prevent various other types of cancer.
The FDA’s warning letter specifically addresses a television advertisement and a podcast episode that promote Anktiva, the primary product of ImmunityBio Inc., a company acquired by Soon-Shiong, who is also the owner of the Los Angeles Times.
The letter states, “The FDA has determined that the TV ad and podcast are false or misleading. Furthermore, the TV ad and podcast provide evidence that Anktiva is intended for new uses for which it lacks approval, and for which its labeling does not provide adequate directions for use.” This assertion is critical, as it underscores the need for accurate communication regarding drug capabilities.
Following the release of the FDA letter, ImmunityBio’s shares experienced a decline of more than 21%, closing at $7.42.
Anktiva received FDA approval in 2024 for patients suffering from a difficult-to-treat form of bladder cancer. The company has been actively pursuing additional FDA approvals to extend the drug’s use to various other cancers, including certain types of lung and pancreatic cancer.
Dr. Soon-Shiong’s remarks came during a January episode of “The Sean Spicer Show,” titled “Is the FDA blocking life-saving cancer treatments?” Within the discussion, he referred to Anktiva as “the most important molecule that could cure cancer,” and claimed that while the drug is currently approved for bladder cancer, “it actually can treat all cancers.” He also mentioned, “We have the therapy to prevent cancer if you were exposed to radiation, and that’s Anktiva.” Such statements have raised significant concerns among regulators.
FDA officials stated that these comments contravene federal regulations governing drug marketing, as they create a misleading impression of Anktiva’s intended use. Furthermore, they highlighted that the podcast failed to include necessary information regarding the drug’s risks and side effects, which can encompass urinary tract infections, pain, chills, and pyrexia. Under FDA regulations, promotional materials for drugs are required to present a balanced view of both risks and benefits.
The warning from the FDA, directed to ImmunityBio CEO Richard Adcock, expressed similar concerns regarding the television advertisement for Anktiva. Both the ad and the podcast inaccurately referred to the drug as a “cancer vaccine,” a classification that the FDA has deemed incorrect.
The agency has provided ImmunityBio with 15 days to rectify the identified issues and respond in writing regarding their compliance plans. As of Tuesday afternoon, the link to the podcast had been removed from ImmunityBio’s official website.
In response to the FDA’s warning, Sarah Singleton, a spokesperson for ImmunityBio, indicated via email that the company takes the FDA’s concerns “very seriously” and intends to collaborate with the agency to address the issues raised in the letter.
It is worth noting that under the previous administration, the FDA intensified its scrutiny of drug manufacturers and online pharmacies, which included monitoring the appearances of company executives on television and podcast platforms.