FDA flags misleading claims for cancer drug by biotech billionaire
Patrick Soon-Shiong
[March 25, 2026]
By MATTHEW PERRONE
WASHINGTON (AP) — Federal health officials posted a warning Tuesday
about misleading statements made by biotech billionaire Dr. Patrick
Soon-Shiong, who recently told podcast listeners that 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.
Company shares fell more than 21% in trading Tuesday to close at $7.42
after the FDA letter 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.
Soon-Shiong's controversial statements came during a January episode of
“The Sean Spicer Show” podcast titled “Is the FDA blocking life-saving
cancer treatments?”
At one point during the interview, Soon-Shiong described his company's
drug as “the most important molecule that could cure cancer.” A few
minutes later, Soon-Shiong — who is the company's executive chairman and
chief medical officer — said that while the drug is approved for bladder
cancer, “it actually can treat all cancers.”
Later in the episode he said, “We have the therapy to prevent cancer if
you were exposed to radiation, and that’s Anktiva.”
FDA regulators said the statements violate federal drug marketing rules
because they “create a misleading impression” of the drug.
[to top of second column]
|
Pharmaceuticals billionaire Dr. Patrick Soon-Shiong waves as
he arrives in the lobby of Trump Tower in New York for a meeting
with President-elect Donald Trump on Jan. 10, 2017. (AP Photo/Evan
Vucci, File)
 Regulators also noted that the
podcast didn't contain any information about risks and side effects
of the drug, which can include urinary tract infections, pain,
chills and pyrexia. Under FDA law, drug promotions are required to
give a balanced view of a drug's risks and benefits.
The FDA warning, addressed to ImmunityBio CEO Richard Adcock, raises
similar concerns with a TV advertisement for Anktiva. Both the ad
and the podcast refer to the company's drug as a “cancer vaccine,”
which the FDA said is false.
The letter gives the company 15 days to correct the problems and
respond to the agency in writing about its plans to comply. By
Tuesday afternoon, a link to the podcast had been removed from
ImmunityBio's website.
Sarah Singleton, spokesperson for Culver City, California-based
ImmunityBio, said via email that the company takes the FDA’s warning
“very seriously,” and plans to “work cooperatively with the agency
to address the matters raised in the letter.”
Under the Trump administration, the FDA has stepped up warnings
against drugmakers as well as online pharmacies, including
appearances by company executives on TV shows and podcasts.
All contents © copyright 2026 Associated Press. All rights reserved |
