FDA warns manufacturer that billionaire's claims about cancer drug Anktiva are misleading
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Washington — Federal health officials posted a warning Tuesday about misleading statements made by biotech billionaire Dr. Patrick Soon-Shiong, who recently told podcast listeners his company's bladder cancer drug may be able to treat, cure or even prevent other types of cancers. In:
Washington — Federal health officials posted a warning Tuesday about misleading statements made by biotech billionaire Dr. Patrick Soon-Shiong, who recently told podcast listeners his company's bladder cancer drug may be able to treat, cure or even prevent other types of cancers.
The warning letter from the Food and Drug Administration takes issue with a TV advertisement and a separate podcast episode promoting Anktiva, the lead product of ImmunityBio Inc. The drugmaker is one of several biotech firms acquired by Soon-Shiong, who also owns the Los Angeles Times.
The "FDA has determined that the TV ad and podcast are false or misleading," the letter says. ... "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."
Company shares fell more than 21% in Tuesday trading to close at $7.42 after the FDA letter was posted online.
Anktiva was approved by the FDA in 2024 for patients with a hard-to-treat form of bladder cancer. ImmunityBio has been working to win FDA approval to expand the drug's use to a number of other conditions, including forms of lung and pancreatic cancer.
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