The FDA’s Office of Prescription Drug Promotion has issued a warning letter to drugmaker ImmunityBio over misleading promotional materials for Anktiva, a bladder cancer drug.
The March 13 letter cited a TV advertisement and a podcast featuring Richard Adcock, president and CEO of ImmunityBio, and Patrick Soon-Shiong, MD, the company’s executive chairman. The agency found the materials misbranded Anktiva by overstating its efficacy and suggesting unapproved uses, including the prevention and treatment of all cancers and administration routes not supported by labeling.
Anktiva is FDA-approved for use in combination with Bacillus Calmette-Guérin for adults with BCG-unresponsive, nonmuscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors. Data supporting approval came from the QUILT-3.032 study, which showed a 62% complete response rate among 77 patients, with 58% maintaining a response for at least 12 months.
The FDA alleged that ImmunityBio’s materials falsely implied Anktiva was effective as a monotherapy and as a cancer “vaccine.” The agency also criticized the omission of risk information and failure to submit the podcast to the FDA prior to dissemination, as required.
ImmunityBio has 15 days to respond with a corrective plan.
