STAT+: FDA slams Soon-Shiong and ImmunityBio for making ‘false and misleading’ claims about a drug
Why it matters: FDA's crackdown on misleading drug claims protects patients and upholds integrity in cancer treatment marketing.
- ImmunityBio, primarily owned by Patrick Soon-Shiong, received a warning letter from the FDA regarding misleading claims about its cancer drug, Anktiva.
- The FDA found that promotional materials for Anktiva suggested it could treat “all cancers” and lead to patients being “cancer free,” claims unsupported by clinical studies.
- Material facts were omitted, including the necessity of using Anktiva in combination with a vaccine, and risks were downplayed or not mentioned at all in the ad and podcast.
- Patrick Soon-Shiong is a controversial figure in the biotech industry, and this incident adds to scrutiny around his ventures, though another STAT News article notes a "buzzy AI doctor startup" is also meeting with the FDA, indicating broader regulatory engagement in health tech.
Biotech mogul Patrick Soon-Shiong and his company ImmunityBio face severe FDA criticism for making "false and misleading" claims about their cancer drug, Anktiva, in promotional materials. The agency specifically cited unsubstantiated assertions that the drug could treat "all cancers" and lead to patients being "cancer free," while omitting crucial information about combination therapy and downplaying risks.
