CULVER CITY, Calif., May 19, 2026
ImmunityBio announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) seeking expanded approval of ANKTIVA® (nogapendekin alfa inbakicept-pmln) plus BCG for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary disease without carcinoma in situ (CIS). The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 6, 2027, marking a major regulatory milestone for the company’s bladder cancer immunotherapy program.
The supplemental filing aims to broaden the currently approved indication of ANKTIVA plus BCG beyond patients with CIS with or without papillary tumors to include patients with papillary-only disease, a significantly larger segment of the NMIBC population. According to ImmunityBio, approximately 85% of the nearly 64,000 NMIBC patients diagnosed annually in the United States present with papillary disease, representing a major unmet need in bladder-sparing cancer treatment. The FDA stated in its filing communication that the review will focus on scientific evidence supporting the biological overlap between papillary disease and CIS, as well as whether efficacy data from CIS-associated disease can reasonably be extrapolated to papillary-only disease.
FDA Review Focuses on Biological Similarities Between CIS and Papillary Disease
ImmunityBio’s application is supported by findings from the Phase 2/3 QUILT 3.032 trial (Cohort B) evaluating ANKTIVA plus BCG in patients with high-grade papillary-only NMIBC. Published in The Journal of Urology, the trial achieved its primary endpoint with a 12-month disease-free survival rate of 58.2%. Secondary outcome data further demonstrated durable disease control and bladder preservation benefits, including 94.9% progression-free survival at 12 months, 82% progression-free survival at 36 months, and 83.1% cystectomy-free survival through three years of follow-up. The therapy also demonstrated a 96% disease-specific survival rate at 36 months, while safety findings remained consistent with previously approved ANKTIVA plus BCG data.
The FDA’s review arrives shortly after the Agency hosted a public workshop titled “Contemporary Issues in Non-Muscle Invasive Bladder Cancer Trial Design and Interpretation” on May 18, 2026. During the workshop, scientific experts and practicing clinicians emphasized that papillary disease and CIS originate from the same cancer-inducing clone and are biologically related forms of NMIBC. Panelists stated that physicians frequently treat papillary-only patients in real-world clinical practice using therapies already approved for CIS-associated disease, even when CIS itself is not detected. ImmunityBio highlighted that these expert opinions align closely with the National Comprehensive Cancer Network (NCCN) decision earlier this year to designate ANKTIVA plus BCG as a Category 2A guideline recommendation for patients with BCG-unresponsive papillary-only NMIBC.
ANKTIVA Could Expand Bladder-Sparing Treatment Options
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ImmunityBio Founder and Executive Chairman Patrick Soon-Shiong stated that the FDA’s acceptance of the supplemental application represents a meaningful step toward expanding access to bladder-preserving immunotherapy options for patients facing limited alternatives beyond radical cystectomy. He noted that the clinical discussions during the FDA workshop reinforced the growing recognition among urologists that papillary-only disease behaves similarly to CIS biologically and should potentially be treated under the same therapeutic framework.
Currently, patients with BCG-unresponsive papillary-only NMIBC often face radical bladder removal surgery due to limited FDA-approved bladder-sparing therapies. ImmunityBio argues that ANKTIVA plus BCG could provide a chemotherapy-free immunotherapy approach capable of delaying or avoiding cystectomy while reducing progression to muscle-invasive bladder cancer. The company also emphasized that an expanded label could improve insurance reimbursement access and broaden physician adoption across the NMIBC treatment landscape.
ANKTIVA previously received FDA approval in April 2024 for adults with BCG-unresponsive NMIBC with CIS with or without papillary tumors. The therapy works by activating the immune system through its proprietary IL-15 receptor agonist mechanism, designed to stimulate natural killer (NK) cells and memory T cells that target bladder cancer cells. ImmunityBio continues advancing its broader Cancer BioShield™ platform, which combines immune activation technologies aimed at generating long-term anti-cancer immune responses while reducing reliance on aggressive chemotherapy and radiation treatments.
Source: ImmunityBio press release
