FDA warns ImmunityBio over Anktiva claims by Patrick Soon-Shiong

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The U.S. Food and Drug Administration on Tuesday posted a warning letter to ImmunityBio, Inc. challenging the way the company and its executives promoted Anktiva, a cancer drug approved for a difficult-to-treat form of bladder cancer. The FDA said the promotion and accompanying remarks created a misleading impression of what the treatment can do, and it cited both a TV advertisement and a podcast episode promoted by ImmunityBio. After the FDA letter was made public, ImmunityBio shares fell more than 21% in trading Tuesday, closing at $7.42.

According to the FDA letter reported by The Associated Press, Soon-Shiong made the statements in a January appearance on “The Sean Spicer Show,” a podcast episode titled “Is the FDA blocking life-saving cancer treatments?” In the interview, the FDA said, Soon-Shiong described Anktiva with sweeping language that went beyond its approved bladder cancer use.

The FDA letter said Soon-Shiong at one point called his company’s drug “the most important molecule that could cure cancer.” The warning letter then took issue with additional claims made by Soon-Shiong in the same episode, including his statement that although the drug is approved for bladder cancer, “it actually can treat all cancers,” as well as a later remark that “We have the therapy to prevent cancer if you were exposed to radiation, and that’s Anktiva.”

The FDA also said the podcast promotion did not include information about risks and side effects of the drug, which the agency said can include urinary tract infections, pain, chills and pyrexia. Under federal drug marketing rules, the FDA said, drug promotions must give a balanced view of a medicine’s risks and benefits.

The FDA letter addressed to ImmunityBio CEO Richard Adcock also raised similar concerns about an ImmunityBio TV advertisement for Anktiva. In both the advertisement and the podcast content, the drug was described as a “cancer vaccine,” a characterization the FDA said was false, according to the AP report.

The FDA letter gave ImmunityBio 15 days to correct the problems it identified and respond to the agency in writing about its compliance plans. By Tuesday afternoon, according to the report, a link to the podcast had been removed from ImmunityBio’s website.

In an email response reported by AP, Sarah Singleton, a spokesperson for the Culver City, California-based company, said ImmunityBio takes the warning “very seriously.” Singleton said the company plans to “work cooperatively with the agency to address the matters raised in the letter.”

The episode and advertisement were tied to an effort to expand Anktiva’s potential uses. Anktiva was approved by the FDA in 2024 for patients with hard-to-treat bladder cancer, and ImmunityBio has been working to win FDA approval to expand the drug’s use to other conditions, including forms of lung and pancreatic cancer.

AP also reported that under the Trump administration the FDA has stepped up warnings involving drugmakers as well as online pharmacies, including appearances by company executives on TV shows and podcasts.