The FDA this month issued a warning letter to ImmunityBio regarding promotional statements about cancer drug Anktiva that the agency claims are “false or misleading.”
The missive marks the first full-fledged warning letter of 2026 from the FDA’s Office of Prescription Drug Promotion (OPDP), arriving amid a steady stream of less-severe untitled letters about marketing mishaps.
In fact, one untitled letter issued early this year went to ImmunityBio, echoing concerns from a previous September 2025 letter and taking issue with certain statements about Anktiva’s efficacy on the bladder cancer drug’s patient- and clinician-facing websites.
In the March 13 warning letter, which was made public Tuesday, the OPDP wrote that it “is concerned that, despite receiving these previous Untitled Letters, ImmunityBio continues to promote Anktiva in a similarly misleading manner.”
The warning letter homes in on a TV ad for Anktiva featuring ImmunityBio CEO Richard Adcock and Patrick Soon-Shiong, M.D., the company’s executive chairman and global chief scientific and medical officer, as well as a January podcast episode in which Soon-Shiong discussed the drug with host Sean Spicer.
The commercial is no longer available online, and while the podcast episode—titled “Is the FDA BLOCKING Life Saving Cancer Treatments?”—has been removed from ImmunityBio’s website, it’s still live on YouTube and podcast platforms.
According to the FDA, both the TV ad and podcast episode make misleading claims about Anktiva’s efficacy and directions for use while minimizing or omitting risk information and fail to list the drug’s full FDA-approved indication.
Among a broad swath of objections under those headings, the FDA repeatedly took issue with Soon-Shiong’s claims that Anktiva “actually can treat all cancers” and can “prevent cancer if you were exposed to radiation”—despite its approval only in one type of bladder cancer—and his characterization of the med as “a single jab” and a “little vial that you inject subcutaneously,” though Anktiva is approved only for intravesical use.
The FDA gave ImmunityBio 15 days to respond to the warning letter’s concerns and either explain why the promotional materials don’t violate the agency’s rules or offer a plan to discontinue and correct any misleading statements.
Since the letter went live on the FDA’s database Tuesday morning, ImmunityBio’s stock has taken a tumble, plummeting about 24% from its opening price of just over $9 to fall below $7 by midday.
In a statement sent to Fierce Pharma Marketing, ImmunityBio acknowledged receipt of the warning letter, writing, “We take the FDA’s concerns seriously and have initiated a review of the letter with our legal and regulatory teams.”
“We intend to respond to the FDA within the requested timeframe and to work cooperatively with the agency to address the matters raised in the letter,” the statement continued. “We are committed to maintaining the highest standards for scientific accuracy and regulatory compliance. We remain deeply committed to accurate, balanced, and compliant communications about ANKTIVA and its FDA-approved indication.”