FDA Issues Warning Letter to ImmunityBio Over Misleading Cancer Drug Claims by Patrick Soon-Shiong
核心洞察
The FDA issued a warning letter to ImmunityBio after biotech billionaire Patrick Soon-Shiong made misleading claims about Anktiva, stating it could cure all cancers and prevent radiation-induced cancer.
Anktiva is currently approved only for hard-to-treat bladder cancer, but Soon-Shiong promoted it as a universal cancer treatment during a podcast appearance.
The FDA cited violations of federal drug marketing rules for creating misleading impressions and failing to provide balanced risk-benefit information.
The Food and Drug Administration issued a warning letter Tuesday to ImmunityBio Inc. over misleading promotional statements made by biotech billionaire Dr. Patrick Soon-Shiong regarding the company's bladder cancer drug Anktiva. The regulatory action sent company shares tumbling more than 24% in trading.
Controversial Claims Trigger FDA Action
The warning letter addresses statements Soon-Shiong made during a January episode of The Sean Spicer Show podcast titled "Is the FDA blocking life-saving cancer treatments?" During the interview, Soon-Shiong, who serves as the company's executive chairman and chief medical officer, described Anktiva as "the most important molecule that could cure cancer."
Soon-Shiong further claimed that while the drug is approved for bladder cancer, "it actually can treat all cancers." He also stated: "We have the therapy to prevent cancer if you were exposed to radiation, and that's Anktiva."
FDA regulators determined these statements violate federal drug marketing rules because they "create a misleading impression" of the drug's capabilities and approved uses.
Current Approval Status and Development Pipeline
Anktiva received FDA approval in 2024 specifically for patients with a hard-to-treat form of bladder cancer. ImmunityBio is currently working to expand the drug's approved indications to other conditions, including forms of lung and pancreatic cancer, but these applications remain under regulatory review.
The FDA warning letter, addressed to ImmunityBio CEO Richard Adcock, also takes issue with a television advertisement for Anktiva that contains similar promotional violations.
Regulatory Violations and Safety Information
Both the podcast appearance and TV advertisement referred to Anktiva as a "cancer vaccine," which the FDA stated is false. Additionally, regulators noted that the promotional materials failed to include required information about the drug's risks and side effects.
According to the FDA, Anktiva's known side effects can include urinary tract infections, pain, chills and pyrexia. Federal drug marketing law requires promotional materials to provide a balanced view of both benefits and risks.
Company Response and Compliance Timeline
Sarah Singleton, spokesperson for the Culver City, California-based company, said via email that ImmunityBio takes the FDA's warning "very seriously" and plans to "work cooperatively with the agency to address the matters raised in the letter."
The FDA has given the company 15 days to correct the identified problems and respond in writing about its remediation plans. By Tuesday afternoon, the link to the controversial podcast had been removed from ImmunityBio's website.
Broader Regulatory Context
The warning represents part of increased FDA enforcement activity under the current administration, with regulators stepping up warnings against drugmakers and online pharmacies for violations including company executive appearances on TV shows and podcasts that contain misleading promotional content.