Overview
- ImmunityBio received a warning letter Tuesday from the FDA’s Office of Prescription Drug Promotion over a TV ad and a podcast that promoted Anktiva.
- The agency said the materials claimed the drug could treat all cancers, prevent cancer after radiation exposure, or work as a single injection, none of which are FDA approved or supported by data.
- The FDA ordered a written remediation plan and corrective communications to audiences that saw the content, and the podcast link was removed from the company’s website.
- Shares fell more than 20% after the warning became public, following Monday’s rally on Macau’s authorization for Anktiva with BCG, highlighting investor swings tied to regulatory news.
- Anktiva is approved only for BCG‑unresponsive non‑muscle invasive bladder cancer with carcinoma in situ, supported by trial data showing a 71% complete response rate, while new NCCN guidance also lists the regimen for papillary‑only disease beyond the current label.