FDA warns manufacturer that billionaire’s claims about cancer drug Anktiva are misleading
The Food and Drug Administration (FDA) issued a warning against biotech billionaire Dr. Patrick Soon-Shiong for making misleading statements about his company’s bladder cancer drug, Anktiva. The FDA took issue with a TV advertisement and a podcast episode in which Soon-Shiong claimed that the drug could treat, cure, or prevent other types of cancers. The FDA stated that these statements were false and misleading, as well as lacking approval for new uses.
The FDA warning caused a significant drop in ImmunityBio Inc.’s shares, with a decrease of more than 21% in Tuesday trading. Anktiva was initially approved by the FDA in 2024 for hard-to-treat bladder cancer, but the company has been seeking approval to expand its use to other conditions such as lung and pancreatic cancer.
During a podcast episode titled “Is the FDA blocking life-saving cancer treatments?” on “The Sean Spicer Show,” Soon-Shiong made controversial statements about Anktiva, referring to it as “the most important molecule that could cure cancer” and claiming it could treat all cancers and even prevent cancer if exposed to radiation. These statements were deemed misleading by FDA regulators, as they did not provide a balanced view of the drug’s risks and benefits, which include urinary tract infections, pain, chills, and pyrexia.
The FDA warning also addressed a TV advertisement for Anktiva, where the drug was referred to as a “cancer vaccine,” which the FDA determined to be false. The FDA gave ImmunityBio Inc. 15 days to correct the issues and respond in writing about their plans to comply. The podcast episode was promptly removed from the company’s website following the warning.
In response to the FDA warning, ImmunityBio spokesperson Sarah Singleton stated that the company takes the matter seriously and plans to cooperate with the agency to address the concerns raised in the letter. It’s worth noting that under the Trump administration, the FDA has increased warnings against drugmakers and online pharmacies for misleading marketing practices.
Overall, the FDA warning serves as a reminder of the importance of accurate and transparent communication in the pharmaceutical industry, especially when promoting new drugs and treatments. Compliance with FDA regulations is crucial to ensure the safety and well-being of patients who rely on these medications for their health and well-being.
