WASHINGTON (AP) — Federal health officials issued a warning this Tuesday concerning misleading claims made by Dr. Patrick Soon-Shiong, a biotech billionaire. During a podcast episode, he stated that his company’s bladder cancer drug, Anktiva, might be able to treat, cure, or even prevent other types of cancers.
The Food and Drug Administration (FDA) sent a warning letter criticizing both a TV advertisement and the podcast promoting Anktiva. Soon-Shiong, who holds positions as the executive chairman and chief medical officer at ImmunityBio Inc., also owns the Los Angeles Times.
Following the FDA’s warning, the company's stock dropped over 24% on Tuesday, signaling investor concern. Anktiva, which received FDA approval in 2024 for a specific type of bladder cancer, is currently under review for broader applications, including lung and pancreatic cancer.
In a January episode titled “Is the FDA blocking life-saving cancer treatments?” Soon-Shiong characterized Anktiva as “the most important molecule that could cure cancer,” later claiming it can treat all cancers. He further stated, “We have the therapy to prevent cancer if you were exposed to radiation, and that’s Anktiva.”
The FDA contends that the statements made in the podcast violate federal drug marketing regulations, creating a misleading perception of the drug while failing to address its potential risks. Side effects of Anktiva can include urinary tract infections, pain, chills, and fever, which were absent from the promotional commentary. According to FDA regulations, drug promotions must present a balanced view of risks and benefits.
The FDA warning, directed at ImmunityBio's CEO, Richard Adcock, calls into question both the podcast and the advertisement’s description of Anktiva as a “cancer vaccine,” a classification the FDA argues is false. The company is mandated to rectify these issues within 15 days and report back to the FDA accordingly. By Tuesday afternoon, the link to the podcast had been removed from ImmunityBio’s website.
Responding to the agency's concerns, Sarah Singleton, a spokesperson for ImmunityBio, emphasized the company’s commitment to addressing the FDA's points and cooperating fully with the review process. The FDA, under the previous Trump administration, has intensified warnings against misleading drug promotions, particularly those linked to media appearances by biotech executives.
