ImmunityBio has resubmitted its sBLA to the FDA for ANKTIVA plus BCG in BCG-unresponsive papillary NMIBC, supported by long-term data from the QUILT 3.032 trial showing durable bladder preservation and disease control.
Written By: Chikkula Pavan Kumar, PharmD
Reviewed By: Pharmacally Editorial Team
ImmunityBio announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of its resubmitted supplemental Biologics License Application (sBLA) for ANKTIVA® (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary tumors.
The resubmission follows discussions with the FDA that began in January 2026, during which the agency requested additional data to support its review. ImmunityBio submitted the requested information in February 2026. After further feedback requesting updated efficacy data, the company resubmitted the application with long-term follow-up data for patients with papillary-only NMIBC, and the FDA has now confirmed receipt of the filing.
Pharmacally previously reported on the company’s FDA resubmission planning for ANKTIVA earlier this year, which can be read below
The application is supported by long-term results from the QUILT 3.032 Phase 2/3 trial (Cohort B) in 80 patients with high-grade papillary-only NMIBC. As published in The Journal of Urology (Chang et al., 2025), the study met its primary endpoint with a 12-month disease-free survival (DFS) rate of 58.2% (95% CI: 46.6–68.2%).
Long-term outcomes showed disease-specific survival of 96.0% at 36 months, with median survival not yet reached. Progression-free survival was 94.9% at 12 months and 83.1% at 36 months, while cystectomy-free survival remained 92.2% at 12 months and 81.8% at 36 months, indicating that more than 80% of patients avoided radical bladder removal through three years of follow-up.
Commenting on the development, Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio, said that the long-term findings in papillary NMIBC demonstrate durable bladder preservation and prolonged disease-free survival consistent with the therapy’s immunologic mechanism.
He also referenced recent remarks by FDA Commissioner Dr. Marty Makary in The New England Journal of Medicine, which highlighted the importance of a “plausible mechanism of action” as an emerging regulatory consideration.
Separately, ImmunityBio noted that ANKTIVA has also received approval from the Saudi Food and Drug Authority (SFDA) in combination with checkpoint inhibitors for patients with second-line or later metastatic non-small cell lung cancer (NSCLC) whose disease has progressed after standard therapies.
In this treatment setting, the company pointed to the PRAGMATICA-LUNG (SWOG S2302) trial, which evaluated pembrolizumab plus ramucirumab versus docetaxel and did not demonstrate improved survival compared with docetaxel chemotherapy, with a median overall survival of about nine months.
ImmunityBio plans to present the clinical data supporting the SFDA approval and continue discussions with regulators regarding potential treatment options for patients with advanced NSCLC who have exhausted available therapies.
Reference
ImmunityBio Announces Resubmission of Supplemental BLA to the FDA for ANKTIVA® Plus BCG in BCG-Unresponsive NMIBC with Papillary Disease Following Agency Review of Additional Data, 09 March 2026, ImmunityBio Announces Resubmission of Supplemental BLA to the FDA for ANKTIVA® Plus BCG in BCG-Unresponsive NMIBC with Papillary Disease Following Agency Review of Additional Data – ImmunityBio
Chang SS et al, Prolonged Progression-Free Survival, Disease-Free Survival, and Cystectomy Avoidance With IL-15 Receptor Lymphocyte-Stimulating Agent NAI Plus Bacillus Calmette-Guérin in Bacillus Calmette-Guérin-Unresponsive Papillary-Only Nonmuscle-Invasive Bladder Cancer. J Urol. 2026 Jan;215(1):44-56. Epub 2025 Sep 16. PMID: 40956664; PMCID: PMC12708036. https://doi.org/10.1097/ju.0000000000004782
QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in Patients with BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer, ClinicalTrials.gov ID NCT03022825, https://clinicaltrials.gov/study/NCT03022825
About the Writer
Chikkula Pavan Kumar, PharmD He is a Doctor of Pharmacy with a keen interest in clinical pharmacy, pharmacovigilance, and evidence-based practice. In his words, he is passionate about patient safety and translating complex medical information into clear, research-driven communication.