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FDA Slams Cancer Drug Ads as Misleading
24 Mar
Summary
- FDA warns ImmunityBio's cancer drug ads are misleading.
- Promotional materials claimed Anktiva could cure all cancer.
- Shares fell 20% following the FDA's warning letter.
The U.S. Food and Drug Administration (FDA) has issued a warning letter concerning promotional materials for ImmunityBio's cancer therapy, Anktiva. The FDA found that a television advertisement and a podcast promoting Anktiva were false or misleading, violating federal law. These communications, which featured the company's CEO and Executive Chairman, created an inaccurate impression about the drug's capabilities.
Specifically, the FDA indicated that the direct-to-consumer materials suggested Anktiva could cure and prevent all types of cancer. The agency also noted that the promotions implied the drug could be used as a single-agent therapy, a cancer vaccine, or prevent cancer recurrence. ImmunityBio's shares fell by 20% on Tuesday following the FDA's announcement, which was issued on March 13.
Anktiva received FDA approval in April 2024 for treating a specific type of bladder cancer. The FDA emphasized that the misleading claims are concerning from a public health perspective. ImmunityBio has not yet responded to requests for comment.
