Patrick Soon-Shiong, a controversial figure in the biotech industry, was harshly criticized by the Food and Drug Administration for making several false and misleading claims about a cancer treatment in television ads and a podcast.
In a March 13 warning letter to ImmunityBio, which is primarily owned and controlled by Soon-Shiong, the agency found fault with numerous comments about the therapy, called Anktiva. The drug is marketed as a treatment for a type of bladder cancer, but the FDA noted both the ad and podcast suggested it was able to treat “all cancers.”
The agency also noted that material facts were omitted — notably, that Anktiva must be used in combination with a vaccine. It also noted that risks were downplayed in the ad and never mentioned in the podcast, and that both the ad and podcast indicated that patients treated with Anktiva would be “cancer free,” which was not supported by clinical studies.
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