ImmunityBio (NASDAQ: IBRX) has resubmitted a supplemental biologics license application to the U.S. Food and Drug Administration for its ANKTIVA treatment combined with BCG in patients with BCG-unresponsive non-muscle invasive bladder cancer containing papillary tumors.

The FDA acknowledged receipt of the resubmitted filing after reviewing additional data provided by the company in February 2026. The resubmission followed ongoing discussions with the FDA beginning in January 2026, during which the agency requested additional information to support its review without requiring new clinical trials.

The application is supported by long-term results from the QUILT 3.032 Phase 2/3 trial involving 80 patients with high-grade papillary-only non-muscle invasive bladder cancer. The study met its primary endpoint with a 12-month disease-free survival rate of 58.2%.

According to the press release, approximately 60,000 people are diagnosed with non-muscle invasive bladder cancer annually in the U.S., with approximately 70% presenting with papillary disease.

ANKTIVA received FDA approval in 2024 for BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors. The current supplemental application specifically addresses papillary-only disease.

The company stated that patients treated with intravesical ANKTIVA plus BCG demonstrated a 96.0% disease-specific survival rate at 36 months in the clinical trial. Bladder preservation remained at 92.2% at 12 months and 81.8% at 36 months.

The Saudi Food and Drug Authority recently approved ANKTIVA in combination with checkpoint inhibitors for patients with second-line and later metastatic non-small cell lung cancer whose disease has progressed after standard therapies.