ImmunityBio’s ANKTIVA Plus BCG Added To NCCN 2026 Guidelines For Broader Bladder Cancer Use

ImmunityBio, Inc. announced that the National Comprehensive Cancer Network (NCCN) has updated its 2026 Clinical Practice Guidelines in Oncology for Bladder Cancer to include ANKTIVA® in combination with BCG for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) who have papillary-only disease.

The revision expands prior guideline recommendations, which previously covered patients with carcinoma in situ (CIS) with or without papillary tumors. The update now recognises papillary-only NMIBC patients as candidates for treatment with ANKTIVA plus BCG. Both recommendations carry a Category 2A designation, reflecting uniform expert consensus based on lower-level evidence. The NCCN reference for papillary-only disease represents a use that is not currently included in the U.S. FDA-approved label.

“These updated NCCN guideline recommendations in bladder cancer represent an important milestone for patients with BCG-unresponsive NMIBC papillary-only disease who have exhausted standard BCG therapy,” said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. “The addition of ANKTIVA plus BCG for papillary-only disease in the NCCN guidelines reflects the growing body of clinical data evaluating ANKTIVA in this patient population and reinforces our commitment to developing comprehensive treatment solutions that address the full spectrum of patients living with BCG-unresponsive NMIBC. We welcome these updated guideline recommendations and await the FDA’s review of ANKTIVA plus BCG for this indication.”

ANKTIVA® (nogapendekin alfa inbakicept-pmln) is an immunotherapy designed to stimulate natural killer (NK) cells and T cells and has demonstrated durable clinical responses. The guideline update draws on data from ImmunityBio’s bladder cancer development program, including findings from the QUILT-3.032 study, which evaluated ANKTIVA plus BCG in patients with papillary-only NMIBC (Cohort B). The NCCN guidelines are created by multidisciplinary expert panels and updated regularly as new evidence emerges. They are widely used by clinicians, patients, payers, and policymakers to guide cancer treatment decisions and standards of care.

“This update is an important step in the continued evolution of clinical guidance for patients with BCG-unresponsive NMIBC and validates the growing role of immune-based therapies in the treatment landscape,” said Richard Adcock, President and CEO of ImmunityBio.

From a commercial perspective, coverage and reimbursement decisions remain the responsibility of individual payers and may vary by policy. ANKTIVA received approval from the U.S. Food and Drug Administration in April 2024 for use with BCG in BCG-unresponsive NMIBC CIS with or without papillary tumors. It was later assigned a permanent J-code (J9028) by the Centers for Medicare & Medicaid Services in January 2025, and the therapy is now covered by insurance plans representing more than 100 million insured individuals in the U.S.