The National Comprehensive Cancer Network has updated its clinical practice guidelines for bladder cancer to include ANKTIVA in combination with BCG for treating patients with BCG-unresponsive non-muscle invasive bladder cancer with papillary-only disease.

ImmunityBio (NASDAQ: IBRX) announced the guideline update expands previous recommendations that covered patients with carcinoma in situ. The new Category 2A recommendation covers papillary-only disease patients based on clinical data from the company's QUILT-3.032 study.

The guideline reference includes a use not currently approved by the U.S. Food and Drug Administration. ANKTIVA received FDA approval in April 2024 for BCG-unresponsive NMIBC with carcinoma in situ with or without papillary tumors.

ANKTIVA is an interleukin-15 receptor agonist designed to activate natural killer cells and T cells. The drug received a permanent J-code from the Centers for Medicare & Medicaid Services in January 2025 and has insurance coverage for more than 100 million patients in the United States.

"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," said Patrick Soon-Shiong, the company's founder and executive chairman.

The NCCN guidelines are developed by expert panels and updated as new clinical evidence becomes available. They are used by physicians, patients, and payers to inform treatment decisions.

Coverage and reimbursement decisions are made independently by payers and may vary based on plan design and medical policy, according to the company's press release.