The FDA issued a warning letter on March 13, 2026, to ImmunityBio for false and misleading claims in a TV ad and a January podcast by Patrick Soon-Shiong, suggesting Anktiva can cure or prevent all cancers, beyond its approval for BCG-unresponsive NMIBC with CIS.123
Anktiva is FDA-approved only for use in combination with BCG for specific bladder cancer patients, not as a monotherapy or for other cancers like lung cancer.12
The FDA required a response within 15 days, noting prior untitled letters to ImmunityBio subsidiaries for similar issues.2
ImmunityBio stated it will work cooperatively with the FDA and has established new protocols to ensure promotional communications are accurate, balanced, and compliant.14
Following the FDA letter's posting, ImmunityBio shares fell over 21%.3
Sources:
1. https://pharmaphorum.com/news/immunitybio-warned-fda-over-misleading-anktiva-content
2. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/immunitybio-inc-725468-03132026
3. https://www.cbsnews.com/news/fda-warns-manufacturer-that-billionaires-claims-about-cancer-drug-anktiva-are-misleading/
4. https://www.fiercepharma.com/marketing/immunitybio-establish-new-protocols-clear-claims-related-its-cancer-drug