CULVER CITY, October 15, 2026 — The U.S. Food and Drug Administration has expanded the approval of Anktiva in combination with BCG to include adults with BCG-unresponsive, high-grade papillary-only non-muscle-invasive bladder cancer, marking the first treatment specifically approved for this patient group.
FDA Broadens Anktiva Use for Papillary-Only Bladder Cancer
The expanded indication covers patients whose cancer has not responded to standard BCG therapy and whose tumors are papillary-only, without carcinoma in situ. According to ImmunityBio, this approval follows the agency’s review of clinical data from the QUILT-3.032 trial, in which 62% of 77 patients achieved a complete response. Among those responders, 58% maintained the response for at least 12 months and 40% for at least 24 months. The treatment maintains a tolerable safety profile, with most treatment-related adverse events being grade 1 to 2.
Treatment Addresses Large Share of NMIBC Patients
Papillary-only tumors represent approximately 85% of the non-muscle-invasive bladder cancer patient population, according to the company’s announcement. Non-muscle invasive bladder cancer accounts for about 80% of all bladder cancer diagnoses in the United States. By extending Anktiva plus BCG to this group, the FDA has broadened access to a bladder-preserving option for a significant portion of patients who previously had few alternatives after BCG failure.
ImmunityBio Stock Rises on Regulatory News
ImmunityBio stock climbed 1.12% to $9.91 following the FDA announcement, as reported by financial news outlets. The gain reflects investor response to the expanded label, which now includes both carcinoma in situ and papillary-only disease under the approved use of Anktiva with BCG. The company states that the approval supports its goal of advancing immunotherapy approaches that harness the patient’s immune system for durable outcomes.
Background on Bladder Cancer Forms and Treatment Pathways
Non-muscle-invasive bladder cancer develops in the bladder’s inner lining without invading the muscle layer. Although the cancer has not reached the bladder muscle, high-grade tumors can return after treatment and may progress into more advanced disease. Treatment commonly begins with BCG immunotherapy, which stimulates the immune system inside the bladder to attack cancer cells. However, some patients continue to experience persistent or recurring cancer despite receiving BCG. Anktiva was previously approved for adults with BCG-unresponsive bladder cancer involving carcinoma in situ (CIS), with or without papillary tumors. The latest approval extends its use to eligible patients with high-grade papillary tumors who do not have CIS. For people whose cancer has not responded to standard BCG treatment, the expanded indication provides another bladder-preserving treatment option. However, treatment decisions must still consider the risk of disease progression and whether surgery may be more appropriate.
Key Trial Data and Regulatory Approach Supporting the Expansion
The expanded approval is based on the FDA’s review of available scientific information, including the previously demonstrated efficacy of ANKTIVA plus BCG in patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumors. In Cohort A of the QUILT-3.032 trial, 62% of 77 patients achieved a complete response (95% CI: 51, 73); among responders, 58% maintained their response for at least 12 months. Another 40% maintained their response for at least 24 months, demonstrating sustained treatment effect. The decision also introduces a new regulatory approach that allows scientific evidence from closely related forms of bladder cancer to support expanded treatment approvals. This is the first FDA approval to include BCG-unresponsive NMIBC with papillary-only tumors. With this FDA approval, access to ANKTIVA plus BCG expands to include all patients with BCG-unresponsive NMIBC.
Sources
- FDA Expands Anktiva Approval for Bladder Cancer Patients
- FDA Expands ANKTIVA® Approval for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer to Cover Both Papillary and CIS Disease
- ImmunityBio (IBRX) Stock: Climbs as FDA Expands ANKTIVA Approval for Bladder Cancer
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