FDA issues warning letter to ImmunityBio over misleading promotional claims about ANKTIVA in TV advertising and a podcast interview, citing unsupported statements suggesting the therapy could treat multiple cancers beyond its approved bladder cancer indication.
Written By: Vennela Reddy, BPharm
Reviewed By: Pharmacally Editorial Team
The U.S. Food and Drug Administration (FDA) has issued a warning letter on March 13, 2026 (posted March 24, 2026), to ImmunityBio citing false or misleading promotional claims related to its cancer immunotherapy ANKTIVA (nogapendekin alfa inbakicept-pmln).
According to the FDA’s Office of Prescription Drug Promotion (OPDP), the agency identified misleading statements about ANKTIVA in a direct-to-consumer television advertisement and a podcast interview featuring ImmunityBio leadership, including Executive Chairman Patrick Soon‑Shiong. The agency stated that the promotional communications suggested the therapy could treat a broad range of cancers and function as a universal cancer treatment, claims the FDA said are not supported by available evidence.
The FDA noted that statements made during the podcast implied the therapy could treat “all cancers,” despite the drug being approved only for a limited bladder cancer indication. The regulator said such claims expand the drug’s benefits beyond the approved labeling and may create a misleading impression about its clinical effectiveness.
The agency also criticized the promotional materials for failing to adequately communicate the drug’s risks. According to the FDA, the communications minimized or omitted important safety information, which could prevent patients and healthcare professionals from making informed treatment decisions.
ANKTIVA was approved by the FDA in 2024 for the treatment of BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, in combination with BCG therapy. The therapy is administered intravesically and works by activating natural killer (NK) cells and T cells through interleukin-15 signaling to enhance anti-tumor immune responses.
In its warning letter, the FDA instructed ImmunityBio to immediately stop or correct the misleading promotional materials and submit a written response within 15 working days outlining the steps the company will take to address the violations.
This warning letter to ImmunityBio reflects the FDA’s ongoing effort to tighten oversight of prescription drug promotion and signals that the agency is prepared to take enforcement action when companies make unsupported or exaggerated claims about approved therapies.
Reference
WARNING LETTER, ImmunityBio, Inc. MARCS-CMS 725468, March 13, 2026, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/immunitybio-inc-725468-03132026
About the Writer
Vennela Reddy, B.Pharm is a pharmacy graduate with a keen interest in clinical research, pharmacovigilance, and medical writing, with a growing focus on publishable and scientific content development. Along with this she also interested in wellness and healthcare writing due to her natural interest in those topics. In her words, she is passionate about translating complex medical data into clear, evidence-based communication.