USFDA Pulls Up ImmunityBio Over Misleading Claims for Cancer Drug ANKTIVA

New Delhi: The U.S. Food and Drug Administration (USFDA) has issued a warning to ImmunityBio, stating that its promotional materials for cancer drug ANKTIVA (nogapendekin alfa inbakicept) are false and misleading, violate the Federal Food, Drug, and Cosmetic Act, and misbrand the product by exaggerating its efficacy, promoting unapproved uses, and failing to adequately communicate risks.

The action follows a review by the FDA’s Office of Prescription Drug Promotion (OPDP) of a direct-to-consumer (DTC) television advertisement and a podcast titled “Is the FDA BLOCKING Life Saving Cancer Treatments?”, featuring Dr Patrick Soon-Shiong, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio.

The podcast originally aired on The Sean Spicer Show on January 19, 2026, and can also be accessed through ImmunityBio’s website.2 The FDA Bad Ad Program also received complaints regarding promotional communications for Anktiva. FDA has determined that the TV ad and podcast are false or misleading.

Thus, the TV ad and podcast misbrand Anktiva and make the distribution of the drug in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Furthermore, the TV ad and podcast provide evidence that Anktiva is intended for new uses for which it lacks approval, and for which its labeling does not provide adequate directions for use.

In addition, the podcast was not submitted at the time of initial dissemination or publication as required by 21 CFR 314.81(b)(3)(i). These violations are concerning from a public health perspective because the promotional communications create a misleading impression that Anktiva, a treatment for a certain type of bladder cancer, can cure and even prevent all cancer. Cancer is the second leading cause of death in the United States and a significant public health concern that affects a vulnerable patient population at increased risk of medical complications and adverse outcomes.

ANKTIVA in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

The PI for Anktiva includes a warning and precaution regarding the risk of metastatic bladder cancer with delayed cystectomy, which can be lethal. The most common adverse reactions reported with use of Anktiva, including laboratory test abnormalities, are increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills, and pyrexia.

Additionally, the DOSAGE AND ADMINISTRATION section of the PI states (in pertinent part, emphasis original):

"For Intravesical Use Only. Do NOT administer by subcutaneous or intravenous or intramuscular routes."

ANKTIVA is approved only for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), and must be used in combination with Bacillus Calmette-Guérin (BCG). However, the promotional materials failed to clearly communicate this limited indication and instead presented broader, unsubstantiated claims.

According to the FDA, the efficacy of ANKTIVA was evaluated in the QUILT-3.032 study, a single-arm trial involving 77 patients. While a complete response rate of 62% was observed, the study design does not support claims of long-term cure or prevention of cancer. The agency emphasized that there is no evidence to support the suggestion that ANKTIVA alone is effective, particularly as the single-agent cohort was discontinued early due to lack of efficacy.

The FDA also raised concerns that the promotional materials incorrectly suggested that ANKTIVA can be administered as an injection, including subcutaneously, whereas the drug is approved only for intravesical use (directly into the bladder). Additionally, the communications either minimized or entirely omitted critical safety information, including warnings and adverse effects, thereby creating a misleading impression of the drug’s safety profile.

The agency further noted that the podcast was not submitted to the FDA at the time of initial dissemination as required under regulatory provisions. It also highlighted that similar concerns had been raised in prior untitled letters issued in September 2025 and January 2026, indicating continued non-compliance by the company.

The FDA has directed ImmunityBio to immediately cease and desist from misleading promotional communications, submit a detailed response within 15 working days, and provide a comprehensive plan for corrective actions, including dissemination of accurate and non-misleading information to the same audience.

The agency warned that failure to comply may result in enforcement actions, including seizure or injunction.