ImmunityBio warned by FDA over 'misleading' Anktiva content

The FDA has sent a warning letter to ImmunityBio over "false and misleading" comments made by its executive chairman, biotech billionaire Patrick Soon-Shiong, on a podcast.

The letter, addressed to ImmunityBio chief executive Richard Adcock, comes from the FDA's Office of Prescription Drug Promotion (OPDP) and takes issue with some of the content of a podcast entitled "Is the FDA BLOCKING Life Saving Cancer Treatments?", which originally aired on 19th January.

The FDA is also unhappy with a TV ad, which features both Adcock and Soon-Shiong, and according to the regulator, makes misleading representations about the efficacy of ImmunityBio's bladder cancer therapy Anktiva (nogapendekin alfa inbakicep), including suggestions that it is "intended for new uses for which it lacks approval."

During an episode of The Sean Spicer Show podcast (still available at the time of writing on YouTube), Soon-Shiong said that IL-15 receptor agonist Anktiva is "approved for bladder cancer, but it actually can treat all cancers," and is "on the path to curing cancer." Later in the stream, he added: “We have the therapy to prevent cancer if you were exposed to radiation, and that’s Anktiva.”

The letter also takes ImmunityBio to task for implying that Anktiva is effective as a monotherapy, rather than a combination therapy in accordance with its approved label, and for not including any information about the risks and side effects of the drug.

"We are not aware of data that support the efficacy claims and representations that Anktiva can 'cure' cancer," writes the FDA in the letter, which is signed by Kathleen Klemm, acting director of the OPDP's division of advertising and promotion.

The TV ad, meanwhile, also oversteps the mark by suggesting Anktiva can be used to treat non-muscle invasive CIS (carcinoma in situ) bladder cancer, but "does not specify that Anktiva is indicated for use in combination with BCG for adult patients with BCG-unresponsive NMIBC with CIS with or without papillary tumours."

The FDA has given ImmunityBio 15 days to respond to the letter, which is dated 13th March, and the company has said it will "work cooperatively with the agency to address the matters raised."

In January, ImmunityBio reported new clinical data that it reckons could support a broadening of Anktiva's label to include high-grade papillary-only NMIBC that is unresponsive to BCG, a group of patients that currently has no approved targeted therapies, and was discussing potential filings with the FDA.

The letter comes amid a crackdown by the FDA on misbranding and misleading statements in promotional materials. Last September, the regulator shared dozens of warning and untitled letters to drugmakers reprimanding them for not meeting standards, including Eli Lilly, CSL Behring, and Novo Nordisk.