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FDA flags misleading claims for cancer drug by biotech billionaire Patrick Soon-Shiong

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FDA flags misleading claims for cancer drug by biotech billionaire Patrick Soon-Shiong
News

News

FDA flags misleading claims for cancer drug by biotech billionaire Patrick Soon-Shiong

2026-03-25 05:41 Last Updated At:05:50

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.

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.

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

FILE - 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)

FILE - 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)

COPENHAGEN, Denmark (AP) — An exit poll pointed to a disappointing showing for the party of Denmark’s prime minister in an election Tuesday, after a campaign that focused on bread-and-butter issues rather than her handling of the crisis over U.S. President Donald Trump 's ambitions toward Greenland.

All three parties in Prime Minister Mette Frederiksen's government looked set to lose ground, according to a poll conducted by the Megafon research institute for broadcaster TV 2. It suggested that left-leaning and right-leaning blocs were likely to fall short of a majority in parliament.

If that is the case, experienced Foreign Minister Lars Løkke Rasmussen — a former prime minister — could play the role of kingmaker. His centrist Moderate party could determine whether Frederiksen can serve a third term at the helm of the European Union and NATO country of some 6 million people.

The 48-year-old Frederiksen is known for strong support of Ukraine in its defense against Russia’s invasion and for a restrictive approach to migration — continuing what has become a tradition in Danish politics.

The poll showed Frederiksen’s center-left Social Democrats remaining the biggest single party with about 21% of the vote, well below the 27.5% they took in the 2022 election.

Frederiksen called the election in February, several months before she had to. She apparently hoped that her resolute image in the standoff over Trump’s push for control of Greenland, rallying European allies behind Denmark, would help her with voters.

Her support had previously waned as the cost of living rose, something that, along with pensions and a potential wealth tax, has been a prominent campaign issue.

Social Democrat lawmaker Morten Klessen said the outgoing government had performed well, but that “there’s been a lot of trouble in Europe and I think our government has had a lot of focus about Ukraine and I think we have lost a little bit in domestic votes for that." He argued that “we need Mette Frederiksen in Europe for solidarity.”

No single party was expected to come anywhere near winning a majority. Denmark’s system of proportional representation typically produces coalition governments, traditionally made up of several parties from either the “red bloc” on the left or the “blue bloc” on the right, after weeks of negotiations.

Frederiksen’s outgoing administration was the first in decades to cross the left-right divide.

Caroline Stage Olsen, a former minister seeking election for the Moderates, argued that “a large part of the Danish population wants a center-focused government.”

She said that "difficult times call for cooperation and call for the parties and for politicians to gather up, man up, woman up and cooperate.”

Two center-right challengers hoped to oust Frederiksen as prime minister. One is in her current government — Defense Minister Troels Lund Poulsen of the Liberal, or Venstre, party, which headed several recent administrations but also appeared on course to win fewer seats Tuesday.

The other was Alex Vanopslagh, 34, of the opposition Liberal Alliance, which calls for lower taxes and less bureaucracy, and for Denmark to abandon its refusal to use nuclear power.

Further to the right, the anti-immigration Danish People’s Party was set to improve significantly on its very weak showing at the last election in 2022.

Greenland, which took up much of the government’s energy in recent months, wasn't a significant issue in the campaign because there is broad agreement on its place in the kingdom.

Frederiksen warned in January that an American takeover of Greenland would amount to the end of NATO. But the crisis has simmered down, at least for now.

After Trump backed down on threats to impose tariffs on Denmark and other European countries that opposed the U.S. taking control of the vast Arctic island, the U.S., Denmark and Greenland started technical talks on an Arctic security deal.

Denmark’s single-chamber parliament, the Folketing, has 179 seats. Of those, 175 go to lawmakers from Denmark itself and two each to representatives from thinly populated Greenland and the kingdom’s other semiautonomous territory, the Faroe Islands.

More than 4.3 million were eligible to vote.

Moulson reported from Berlin. James Brooks in Copenhagen, Denmark contributed to this report.

Ballots will be sorted at the end of the general election in Aalborg, Denmark, Tuesday, March 24, 2026. (Henning Bagger/Ritzau Scanpix via AP)

Ballots will be sorted at the end of the general election in Aalborg, Denmark, Tuesday, March 24, 2026. (Henning Bagger/Ritzau Scanpix via AP)

Danish Prime Minister and Leader of the Social Democrats Mette Frederiksen meets voters at a rally in her support in Copenhagen, Denmark, on Tuesday, March 24, 2026, during the general election. (AP Photo/Sergei Grits)

Danish Prime Minister and Leader of the Social Democrats Mette Frederiksen meets voters at a rally in her support in Copenhagen, Denmark, on Tuesday, March 24, 2026, during the general election. (AP Photo/Sergei Grits)

Jacob Engel Schmidt from the Moderates reacts to the first exit poll during the Danish election for the parliament in Copenhagen, Tuesday, March 24, 2026. (Rasmus Flindt Pedersen/Ritzau Scanpix via AP)

Jacob Engel Schmidt from the Moderates reacts to the first exit poll during the Danish election for the parliament in Copenhagen, Tuesday, March 24, 2026. (Rasmus Flindt Pedersen/Ritzau Scanpix via AP)

Members of The Social Democrats react to the first exit poll during the Danish election for the parliament in Copenhagen, Tuesday, March 24, 2026. (Mads Claus Rasmussen/Ritzau Scanpix via AP)

Members of The Social Democrats react to the first exit poll during the Danish election for the parliament in Copenhagen, Tuesday, March 24, 2026. (Mads Claus Rasmussen/Ritzau Scanpix via AP)

Leader of the Moderates Lars Loekke Rasmussen, center left, and leader of the Danish People's Party Morten Messerschmidt , center, right, speak during TV2's party leader debate 'The Last Answer' in the Common Hall at Christiansborg, in Copenhagen, Monday, March 23, 2026. (Mads Claus Rasmussen/Ritzau Scanpix via AP)

Leader of the Moderates Lars Loekke Rasmussen, center left, and leader of the Danish People's Party Morten Messerschmidt , center, right, speak during TV2's party leader debate 'The Last Answer' in the Common Hall at Christiansborg, in Copenhagen, Monday, March 23, 2026. (Mads Claus Rasmussen/Ritzau Scanpix via AP)

A person exits a polling booth at a polling station at City Hall in Copenhagen, Denmark, on Tuesday, March 24, 2026, during the general election. (AP Photo/Sergei Grits)

A person exits a polling booth at a polling station at City Hall in Copenhagen, Denmark, on Tuesday, March 24, 2026, during the general election. (AP Photo/Sergei Grits)

A man casts a ballot at a polling station at City Hall in Copenhagen, Denmark, on Tuesday, March 24, 2026, during the general election. (AP Photo/Sergei Grits)

A man casts a ballot at a polling station at City Hall in Copenhagen, Denmark, on Tuesday, March 24, 2026, during the general election. (AP Photo/Sergei Grits)

A woman holds a ballot at a polling station at City Hall in Copenhagen, Denmark, on Tuesday, March 24, 2026, during the general election. (AP Photo/Sergei Grits)

A woman holds a ballot at a polling station at City Hall in Copenhagen, Denmark, on Tuesday, March 24, 2026, during the general election. (AP Photo/Sergei Grits)

People line up to receive their ballots at a polling station at City Hall in Copenhagen, Denmark, on Tuesday, March 24, 2026, during the general election. (AP Photo/Sergei Grits)

People line up to receive their ballots at a polling station at City Hall in Copenhagen, Denmark, on Tuesday, March 24, 2026, during the general election. (AP Photo/Sergei Grits)

FILE - Denmark's Prime Minister Mette Frederiksen arrives for the EU summit in Brussels, Jan. 22, 2026. (AP Photo/Geert Vanden Wijngaert, File)

FILE - Denmark's Prime Minister Mette Frederiksen arrives for the EU summit in Brussels, Jan. 22, 2026. (AP Photo/Geert Vanden Wijngaert, File)

FILE - Denmark's Defense Minister Troels Lund Poulsen speaks with the media as he arrives for a meeting of European Union defense ministers at the European Council building in Brussels, Feb. 11, 2026. (AP Photo/Harry Nakos, File)

FILE - Denmark's Defense Minister Troels Lund Poulsen speaks with the media as he arrives for a meeting of European Union defense ministers at the European Council building in Brussels, Feb. 11, 2026. (AP Photo/Harry Nakos, File)

Denmark's Prime Minister Mette Frederiksen, center, Lars Loekke Rasmussen, right, and Pia Olsen Dyhr, left, attend the party leader debate Democracy's Evening on DR1 at the Concert Hall, DR City in Copenhagen, Sunday, March 22, 2026. (Mads Claus Rasmussen/Ritzau Scanpix via AP)

Denmark's Prime Minister Mette Frederiksen, center, Lars Loekke Rasmussen, right, and Pia Olsen Dyhr, left, attend the party leader debate Democracy's Evening on DR1 at the Concert Hall, DR City in Copenhagen, Sunday, March 22, 2026. (Mads Claus Rasmussen/Ritzau Scanpix via AP)

Denmark's Prime Minister Mette Frederiksen, left, and Defense Minister Troels Lund Poulsen, right, attend the party leader debate Democracy's Evening on DR1 at the Concert Hall, DR City in Copenhagen, Sunday, March 22, 2026. (Mads Claus Rasmussen/Ritzau Scanpix via AP)

Denmark's Prime Minister Mette Frederiksen, left, and Defense Minister Troels Lund Poulsen, right, attend the party leader debate Democracy's Evening on DR1 at the Concert Hall, DR City in Copenhagen, Sunday, March 22, 2026. (Mads Claus Rasmussen/Ritzau Scanpix via AP)

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