ImmunityBio’s ANKTIVA® (nogapendekin alfa inbakicept‑pmln) was added to the National Comprehensive Cancer Network’s 2026 Clinical Practice Guidelines for Bladder Cancer on March 17 2026, extending the drug’s recommended use to patients with BCG‑unresponsive non‑muscle invasive bladder cancer (NMIBC) who have papillary‑only disease. The update places ANKTIVA in a Category 2A recommendation for this patient group, a milestone that broadens the potential market for the therapy beyond its current FDA‑approved indication of carcinoma in situ (CIS) with or without papillary tumors.
The guideline inclusion comes at a time when ANKTIVA’s regulatory journey is progressing. The drug received FDA approval in April 2024 for BCG‑unresponsive NMIBC with CIS, and ImmunityBio has resubmitted a supplemental Biologics License Application (sBLA) for the papillary‑only indication after a prior Refusal to File. The NCCN recommendation is based on data from the QUILT‑3.032 Cohort B study, and the company is awaiting FDA review of the sBLA.
Financially, ANKTIVA has driven significant growth for ImmunityBio. Net product revenue reached $113 million in fiscal year 2025, a 700% increase from the previous year, and the drug has secured a permanent J‑code from CMS in January 2025, expanding payer coverage. The guideline endorsement is expected to accelerate adoption, potentially translating into higher sales and a larger addressable market as physicians can prescribe ANKTIVA plus BCG for papillary‑only disease once the FDA approves the indication.
Management highlighted the significance of the update. Patrick Soon‑Shiong, Founder and Executive Chairman, said, "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." He added, "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." Richard Adcock, President and CEO, noted, "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." He also stated that physicians could prescribe ANKTIVA for papillary bladder cancer if included in NCCN guidelines, potentially broadening the therapy's market reach and enhancing the company's competitive position in cancer treatment.
The announcement triggered a notable market reaction, with ImmunityBio’s stock surging approximately 7% in pre‑market trading on March 17 2026. The company had already posted a year‑to‑date return of 314.65% before the guideline update, underscoring the market’s enthusiasm for the expanded indication and the potential upside it represents for future sales growth.
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