WASHINGTON (AP) — The Food and Drug Administration (FDA) issued a warning on Tuesday regarding potentially misleading statements made by biotech billionaire Dr. Patrick Soon-Shiong. The warning is particularly focused on claims that his company, ImmunityBio, made about its bladder cancer drug, Anktiva, suggesting it could treat or even cure various other types of cancer.
The FDA's warning letter was triggered by a recent episode of The Sean Spicer Show podcast, in which Soon-Shiong stated that Anktiva is the most important molecule that could cure cancer and that it could also prevent cancer if one has been exposed to radiation.
ImmunityBio, which recently received FDA approval for Anktiva as a treatment for a challenging form of bladder cancer, has been seeking further approval to expand its use to other cancers, including lung and pancreatic types. However, amid the FDA's warnings, the company's shares experienced a significant decline of over 24% on Tuesday.
The FDA highlighted that both the podcast and a separate TV advertisement referred to Anktiva as a cancer vaccine, a claim the agency disputed. Furthermore, the FDA criticized the promotional efforts for lacking critical information about the drug's risks and side effects, which include urinary tract infections, chills, and fever. Under FDA regulations, promotional materials are required to present a balanced view of both risks and benefits associated with pharmaceuticals.
In response to the FDA's concerns, ImmunityBio has removed the podcast link from its website and committed to working cooperatively with the agency to address the outlined issues. Meanwhile, the FDA has granted ImmunityBio 15 days to rectify the shortcomings raised in the warning letter.
The FDA's scrutiny over misleading statements is not new; the agency has intensified monitoring of drug advertisements, particularly highlighting statements made by company executives that do not align with clinical data.
