FDA accepts ImmunityBio’s sBLA for ANKTIVA plus BCG in BCG‑unresponsive papillary NMIBC without CIS, with a PDUFA date of January 6, 2027. The filing could expand bladder‑sparing immunotherapy access to a larger high‑risk patient population.
Written By: Samiksha Jadhav, BPharm
Reviewed By: Pharmacally Editorial Team
ImmunityBio has secured FDA acceptance of its supplemental Biologics License Application (sBLA) for ANKTIVA in combination with Bacillus Calmette-Guérin (BCG) for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary disease without carcinoma in situ (CIS). The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 6, 2027.
The application could significantly expand access to bladder-sparing immunotherapy for patients with high-risk papillary NMIBC, a substantially larger subgroup within the NMIBC population. ANKTIVA received its initial FDA approval in April 2024 for BCG-unresponsive NMIBC with CIS, with or without papillary tumors.
The FDA said its review will focus on whether biological and clinical similarities between CIS and papillary disease support extrapolating efficacy findings from the previously approved CIS cohort to papillary NMIBC without CIS. The agency also reiterated concerns around interpreting single-arm trial data in papillary disease.
The filing is supported by results from the Phase 2/3 QUILT-3.032 Cohort B study (NCT03022825), which enrolled 80 patients with high-grade papillary NMIBC without CIS. The trial met its primary endpoint, showing a 12-month disease-free survival rate of 58.2% (95% CI: 46.6–68.2%).
Long-term secondary endpoints reinforced durable bladder preservation and disease control. Progression-free survival reached 94.9% at 12 months and 82.0% at 36 months, while cystectomy-free survival remained 92.2% at one year and 83.1% at three years. Disease-specific survival reached 96.0% at 36 months, with median survival not yet reached at the time of submission. Safety findings remained consistent with the established profile of BCG alone.
ANKTIVA is a first-in-class IL-15 receptor agonist fusion complex that activates natural killer cells and CD8+ T cells to restore antitumor immune activity. The therapy has emerged as a bladder-sparing immunotherapy option for patients who otherwise face radical cystectomy following BCG failure.
The submission also gained momentum from a recent FDA public workshop on NMIBC trial design and interpretation, where clinicians and scientific experts discussed the biological overlap between CIS and papillary disease and current real-world treatment practices.
ImmunityBio said the expert discussions aligned with recent NCCN Category 2A guideline support for ANKTIVA plus BCG in BCG-unresponsive papillary NMIBC.
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About the Writer
Samiksha Vikram Jadhav (LinkedIn) is a B. Pharm graduate with a strong academic foundation in pharmaceutical sciences, pharmacology, and drug development. She specializes in pharma market research, with a focused interest in mergers and acquisitions, strategic partnerships, and global pharma and biotech deals. Her work centers on analyzing industry transactions, market positioning, and business strategies, translating complex developments into clear, accurate, and insightful scientific and commercial reporting.