FDA Warns Company Over Cancer Drug Claims

Statements in an advertisement ‘create a misleading impression that Anktiva ... can cure and even prevent all cancer,’ regulators said.

The U.S. Food and Drug Administration in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times

A company called ImmunityBio misled the public by creating an impression that its cancer drug can cure all cancers, the Food and Drug Administration said in a newly released warning.

FDA officials on March 13 told ImmunityBio President and CEO Richard Adcock that they reviewed an advertisement for its drug Anktiva, which is approved for treating bladder cancer. The ad featured Dr. Patrick Soon-Shiong, ImmunityBio’s executive chairman, saying that “there’s an ability to actually create a cancer vaccine so that we can treat the tumor, and it doesn’t come back.”

Regulators also looked at a January podcast episode in which Soon-Shiong said, “We have now discovered and developed this drug ... approved for bladder cancer, but it actually can treat all cancers.”

Soon-Shiong said during the episode—titled “Is the FDA Blocking Life Saving Cancer Treatments?”—that President Donald Trump and White House officials responded favorably to him when he described to them the effectiveness of ImmunityBio’s drug, but that he has not been able to meet with top FDA officials.

Meetings with FDA reviewers happened, and the agency has information showing Anktiva is effective, but it has not yet approved wider use of the drug, he also said.

In contrast, Saudi Arabia has made the drug available for lung cancer in addition to bladder cancer, and officials there have committed to allowing it against other cancers as well, as soon as they review relevant data, Soon-Shiong said.

The comments violate federal law that prohibits misbranding approved drugs, the FDA said.

“These violations are concerning from a public health perspective because the promotional communications create a misleading impression that Anktiva, a treatment for a certain type of bladder cancer, can cure and even prevent all cancer,” officials wrote in the letter.

The missive, released on March 24, directed ImmunityBio to inform the FDA whether it was disputing the findings. Regulators also want the company to develop a plan to spread truthful communications that address the concerns they raised.

“We take the FDA’s concerns seriously and have initiated a review of the letter with our legal and regulatory teams,” a spokesperson for ImmunityBio told The Epoch Times in an email.

“We intend to respond to the FDA within the requested timeframe and to work cooperatively with the agency to address the matters raised in the letter. We are committed to maintaining the highest standards for scientific accuracy and regulatory compliance. We remain deeply committed to accurate, balanced, and compliant communications about Anktiva and its FDA-approved indication.”