WASHINGTON (AP) — The Food and Drug Administration (FDA) has issued a warning regarding potentially misleading statements made by biotech billionaire Dr. Patrick Soon-Shiong. Recently, during episodes of The Sean Spicer Show podcast, Soon-Shiong claimed that his company’s bladder cancer drug, Anktiva, could treat and even prevent other types of cancers.
The FDA's warning letter specifically criticizes a TV advertisement and the podcast episode promoting Anktiva, questioning the validity of Soon-Shiong's claims. Following the announcement, shares of ImmunityBio Inc. experienced a dramatic fall of over 24% in trading.
Anktiva had been approved by the FDA in 2024 for a difficult-to-treat form of bladder cancer, but ImmunityBio is seeking broader approval for its use against other conditions, including lung and pancreatic cancers. Soon-Shiong referred to the drug as “the most important molecule that could cure cancer” and made further assertions about its efficacy against all cancers, which the FDA views as misleading.
The FDA’s regulations require that drug promotions provide a balanced perspective on the risks and benefits, but the podcast omitted important side effects associated with Anktiva, such as urinary tract infections and fever.
The FDA has given ImmunityBio 15 days to address these issues and respond to the agency in writing regarding corrective measures. Following the warning, ImmunityBio acted quickly by removing the podcast from its website.
In a statement, spokesperson Sarah Singleton expressed that the company is taking the FDA's warning seriously and intends to work cooperatively with the agency to resolve these concerns. Under previous regulations set during the Trump administration, the FDA increased scrutiny of drugmakers in their advertising and marketing practices.
The FDA's warning letter specifically criticizes a TV advertisement and the podcast episode promoting Anktiva, questioning the validity of Soon-Shiong's claims. Following the announcement, shares of ImmunityBio Inc. experienced a dramatic fall of over 24% in trading.
Anktiva had been approved by the FDA in 2024 for a difficult-to-treat form of bladder cancer, but ImmunityBio is seeking broader approval for its use against other conditions, including lung and pancreatic cancers. Soon-Shiong referred to the drug as “the most important molecule that could cure cancer” and made further assertions about its efficacy against all cancers, which the FDA views as misleading.
The FDA’s regulations require that drug promotions provide a balanced perspective on the risks and benefits, but the podcast omitted important side effects associated with Anktiva, such as urinary tract infections and fever.
The FDA has given ImmunityBio 15 days to address these issues and respond to the agency in writing regarding corrective measures. Following the warning, ImmunityBio acted quickly by removing the podcast from its website.
In a statement, spokesperson Sarah Singleton expressed that the company is taking the FDA's warning seriously and intends to work cooperatively with the agency to resolve these concerns. Under previous regulations set during the Trump administration, the FDA increased scrutiny of drugmakers in their advertising and marketing practices.
