FDA Expands ImmunityBio’s Anktiva to Papillary-Only BCG-Unresponsive Bladder Cancer

PHARMA REGULATION · ONCOLOGY APPROVAL · OCTOBER 22, 2026 · UNITED STATES

The FDA on October 14 expanded the approved use of ImmunityBio’s Anktiva (nogapendekin alfa inbakicept-pmln), given with the Bacillus Calmette-Guérin (BCG) vaccine, to adults with high-grade papillary-only non-muscle-invasive bladder cancer (NMIBC) that has not responded to BCG. The agency called Anktiva “the first FDA-approved treatment specifically for patients with BCG-unresponsive, high-grade papillary-only disease.” The approval was granted to Altor BioScience, LLC; ImmunityBio markets the drug.

The FDA based the expansion on the trial behind Anktiva’s original approval for BCG-unresponsive NMIBC with carcinoma in situ (CIS), together with scientific similarities between CIS and high-grade papillary-only disease. In that trial, of 77 adults, 62% achieved a complete response, and of those, 58% maintained it for at least 12 months and 40% for at least 24 months. The prescribing information warns that delaying surgery to remove all or part of the bladder can allow the cancer to spread, which can be fatal. “We listen to patients, clinicians, and researchers, and we act when the science supports a new approach,” said R. Angelo de Claro, M.D., director of the FDA’s Oncology Center of Excellence.

The label expansion lands as ImmunityBio, the Culver City, California-based biotech listed on NASDAQ as IBRX, works through an FDA promotion dispute and a crowding market in which its main approved use now faces several rivals.

Earlier this year, on March 13, 2026, the FDA’s Office of Prescription Drug Promotion (OPDP) issued a warning letter to ImmunityBio chief executive Richard Adcock over promotional communications for nogapendekin alfa inbakicept (Anktiva), the company’s interleukin-15 superagonist approved in April 2024 for use alongside BCG in adults with BCG-unresponsive NMIBC with CIS. The OPDP found that a direct-to-consumer television advertisement and a podcast titled ‘Is the FDA BLOCKING Life Saving Cancer Treatments?’ — featuring ImmunityBio’s executive chairman and global chief scientific and medical officer, Patrick Soon-Shiong, M.D. — were ‘false or misleading,’ according to the warning letter published on the FDA’s website.

The agency’s objections were specific and consequential. Soon-Shiong stated on the January 19, 2026 episode of The Sean Spicer Show that Anktiva ‘actually can treat all cancers’ and can ‘prevent cancer if you were exposed to radiation,’ per the FDA warning letter. He also described the treatment as ‘a single jab’ and ‘a little vial that you inject subcutaneously,’ despite Anktiva’s approval being limited to intravesical use — meaning the drug is administered directly into the bladder, not injected under the skin. The FDA characterised these statements as evidence that Anktiva is intended for new uses for which it lacks approval, per the warning letter, which cites the Federal Food, Drug, and Cosmetic Act (FD&C Act).

ImmunityBio’s response and the compliance gap

ImmunityBio responded by implementing what it described as ‘expanded promotional review protocols,’ executive training, and external regulatory oversight, according to a company release reported by Fierce Pharma on April 6, 2026. The company removed the podcast from its corporate website and requested its removal from third-party platforms. In its response to the FDA, ImmunityBio characterised some of Soon-Shiong’s comments as focused on ‘investigational applications’ of Anktiva’s interleukin-15 (IL-15) platform and as ‘aspirational and forward-looking opinions,’ per Fierce Pharma’s reporting. As of April 6, 2026, the podcast remained accessible on The Sean Spicer Show’s listings, according to Fierce Pharma.

The compliance episode came at a commercially sensitive moment. Anktiva is the company’s only US-approved product, and the warning letter introduces a promotional constraint precisely when the competitive field in BCG-unresponsive NMIBC is expanding.

A crowding market and a deteriorating response-rate position

Anktiva’s approval in April 2024 was based on a 62% complete response (CR) rate in BCG-unresponsive NMIBC with CIS, per data cited by Fierce Pharma at the time of approval. That figure now sits below the headline number posted by Johnson & Johnson’s gemcitabine intravesical system, Inlexzo (formerly TAR-200), which the FDA approved on September 9, 2025, for the same indication — BCG-unresponsive NMIBC with CIS, with or without papillary tumors — according to the FDA’s approval package for new drug application (NDA) 219683. In a phase 2b study, Inlexzo achieved a CR rate of 82% without the need for reinduction, with 51% of responders maintaining the response for at least one year, per J&J’s September 9 release as reported by Fierce Pharma. Mark Wildgust, Ph.D., vice president of oncology global medical affairs for J&J Innovative Medicine, described the CR rate as the highest recorded among currently available therapies in this setting in an earlier 2025 interview, according to Fierce Pharma.

Soon-Shiong, for his part, pushed back in an April 2025 interview with Fierce Pharma, stating: ‘There’s nobody [who] has a median of [complete response] of over 45 months’ like Anktiva does — a durability argument rather than a peak-response one. The distinction matters clinically but may be harder to translate into formulary positioning against a competitor whose headline CR figure is numerically higher.

The competitive perimeter widened further on May 28, 2026, when the FDA cleared AstraZeneca’s durvalumab (Imfinzi), a programmed death-ligand 1 (PD-L1) inhibitor, as part of the first immunotherapy combination regimen for patients with high-risk NMIBC who have not previously received BCG — the BCG-naive population, according to AstraZeneca’s May 28 release as reported by Fierce Pharma. That approval is backed by phase 3 data showing a 32% reduction in the risk of high-risk disease recurrence, progression, or death when durvalumab was added to BCG induction and maintenance therapy versus BCG alone, with a median follow-up of 61 months, per AstraZeneca. Neal Shore, M.D., head of the Carolina Urologic Research Center and co-principal investigator in the durvalumab trial, said ‘the durvalumab plus BCG regimen is the first new therapy approved in over 30 years for patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer,’ according to AstraZeneca’s statement. AstraZeneca estimated that more than 31,000 people in the US were treated for high-risk NMIBC in 2024.

Merck & Co.’s pembrolizumab (Keytruda), a programmed death-1 (PD-1) inhibitor, received its FDA nod in the BCG-unresponsive NMIBC with CIS setting in 2020 with a 41% CR rate, per Fierce Pharma’s earlier reporting, and Ferring Pharmaceuticals’ nadofaragene firadenovec (Adstiladrin), a gene therapy, competes in the same indication. The field now spans five approved agents across overlapping NMIBC populations, with distinct mechanisms, administration routes, and response profiles.

A structural supply constraint complicates the picture for Anktiva specifically. Anktiva requires BCG as a combination partner, and Merck & Co. has been the sole US supplier of BCG since 2012, rationing supply since 2019, according to Fierce Pharma. ImmunityBio struck an exclusive manufacturing deal with the Serum Institute of India in May 2024 to produce BCG at scale as a long-term solution to the shortage, per ImmunityBio’s statement at the time. Merck & Co. announced a plan in October 2020 to build a new BCG manufacturing facility in North Carolina, originally anticipated to be completed by late 2025 to late 2026, per a January 2024 Merck & Co. update cited by Fierce Pharma; in a September 2026 letter to clinicians, Merck reported delays at the new facility and said it would update on its opening in the first quarter of 2027, with a phased ramp-up aimed at tripling TICE BCG capacity. Until that capacity comes online, BCG availability remains a practical ceiling on Anktiva’s addressable patient volume — a constraint that does not apply to Inlexzo, which delivers gemcitabine directly and requires no BCG, or to pembrolizumab, which is administered intravenously.

Pharma data intelligence outlet Evaluate projected Anktiva could reach nearly $900 million in 2028 sales, according to Fierce Pharma’s April 2024 reporting — an estimate made before Inlexzo’s approval and before the FDA warning letter.

The deeper tension is structural: ImmunityBio’s durability argument for Anktiva — a median duration of complete response of 45.4 months — is a clinically meaningful differentiator, but it is one that requires time and follow-up data to establish in practice, while a competitor’s 82% peak CR rate is legible to a formulary committee in a single number. Promotional missteps that draw FDA scrutiny narrow the channels through which ImmunityBio can make its case.

Non-Muscle-Invasive Bladder Cancer: Approval Timeline and Regulatory Action

Why this is relevant

Sources: FDA: FDA Approves First Treatment for Certain People With BCG-Unresponsive Bladder Cancer (October 14, 2026) · FDA: ImmunityBio Warning Letter MARCS-CMS 725468, March 13, 2026 · FDA: Inlexzo NDA 219683 Approval Package, September 9, 2025 · Fierce Pharma: ImmunityBio taps Serum Institute for BCG manufacturing · Fierce Pharma: AstraZeneca gains 2nd bladder cancer nod for Imfinzi · Fierce Pharma: J&J aims to fundamentally change bladder cancer treatment · Fierce Pharma: ImmunityBio responds to FDA warning letter with new protocols · Fierce Pharma: J&J’s Inlexzo lands FDA nod · Fierce Pharma: ImmunityBio bags FDA approval for Anktiva · Merck: TICE BCG update letter to clinicians, September 2026