FDA Expands Approval of ImmunityBio's Anktiva for High-Grade Papillary Bladder Cancer

Marking a significant milestone in targeted oncology, the U.S. Food and Drug Administration (FDA) officially granted an expanded indication for ImmunityBio's immunotherapy drug Anktiva (nogapendekin alfa inbakicept) on October 14, 2026. Administered in combination with Bacillus Calmette-Guérin (BCG) vaccine therapy, the IL-15 superagonist complex is now approved to treat adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) presenting high-grade papillary-only tumors. The regulatory clearance expands Anktiva's earlier therapeutic scope, providing an effective non-surgical treatment alternative for individuals facing high risks of disease recurrence or radical cystectomy. Clinical trial data submitted to the FDA demonstrated robust disease-free survival rates and persistent immune activation without severe systemic toxicities typically associated with systemic chemotherapy. Oncologists and urological surgeons lauded the expanded approval, highlighting that therapeutic regimens stimulating local natural killer and T-cell responses offer life-preserving options for patients managing stubborn, high-grade bladder malignancies.

Unlocking New Nonsurgical Treatment Options for Papillary NMIBC

In a major regulatory milestone for urological oncology, the U.S. FDA granted label expansion for ImmunityBio’s first-in-class interleukin-15 (IL-15) receptor agonist, Anktiva (nogapendekin alfa inbakicept-pmln). Used in combination with intravesical BCG, the treatment is now approved for patients with high-grade, papillary-only non-muscle-invasive bladder cancer (NMIBC) who have failed standard BCG therapy.

The decision builds upon Anktiva’s initial April 2024 FDA approval for BCG-unresponsive NMIBC with carcinoma in situ (CIS), with or without papillary tumors. By extending approval to papillary-only disease—which accounts for nearly 85 per cent of all NMIBC cases—the regulatory decision significantly expands nonsurgical therapeutic options for patients facing radical cystectomy (bladder removal).

Overview: Key Regulatory and Clinical Parameters of Anktiva's Label Expansion

Clinical / Regulatory Parameter	Official Details & Trial Specifications
Drug Name & Class	Anktiva (nogapendekin alfa inbakicept-pmln) • IL-15 Receptor Agonist
Sponsoring Company	ImmunityBio, Inc.
Expanded Indication	BCG-unresponsive high-grade papillary-only NMIBC
Supporting Trial	QUILT-3.032 Phase 2/3 Trial (NCT03022825)
Cohort B Clinical Milestone	58.2% 12-Month Disease-Free Survival (DFS) Rate
Mechanism of Action	Activates Natural Killer (NK) cells & CD8+ Killer T cells
Administration Route	Intravesical instillation directly into the bladder alongside BCG

Mechanism of Action and QUILT-3.032 Trial Evidence

Anktiva functions as an immune cell enhancer by complexing a mutated IL-15 protein with an IL-15 receptor-alpha domain. When instilled directly into the bladder, it stimulates natural killer (NK) cells and CD8+ killer T cells while building memory T-cell populations, driving sustained antitumor responses without systemic immunosuppression.

Anktiva Immune Activation Pipeline: ----------------------------------- Intravesical Instillation with BCG ──> IL-15 Receptor Complexing ──> NK Cell & CD8+ T Cell Proliferation ──> Target Papillary Tumor Destruction

The expansion was supported by data from the open-label Phase 2/3 QUILT-3.032 trial. In Cohort B—which specifically evaluated patients presenting with BCG-unresponsive high-grade papillary-only disease—Anktiva plus BCG demonstrated a 12-month disease-free survival (DFS) rate of 58.2 per cent.

"This approval marks an important expansion of Anktiva plus BCG for patients with BCG-unresponsive NMIBC and advances our goal of harnessing the patient's own immune system to achieve durable, tumor-free outcomes," stated Dr. Patrick Soon-Shiong, Founder and Executive Chairman of ImmunityBio.

Safety Profile and Market Outlook

The safety profile observed in papillary-only patients aligns with previous CIS trial findings. Most treatment-related adverse events were localized to the urinary tract—such as dysuria, pollakiuria, hematuria, and urinary urgency—and were primarily Grade 1 or 2 in severity.

With the expanded label in place, ImmunityBio plans to scale commercial distribution to urology centers across the United States immediately, providing a key alternative for patients who previously had few options outside of radical bladder resection.