ImmunityBio Resubmits ANKTIVA Bladder Cancer Application to FDA, Advances Saudi Approvals

ImmunityBio announced that the U.S. Food and Drug Administration has acknowledged receipt of its resubmitted supplemental Biologics License Application for ANKTIVA (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) in BCG-unresponsive non-muscle invasive bladder cancer with papillary tumors. The resubmission follows ongoing discussions with the FDA beginning in January 2026, during which the Agency requested additional data to support its review.

The request did not include the initiation or design of any new clinical trials. ImmunityBio submitted the requested information in February 2026. After reviewing the additional data, the FDA provided feedback in March requesting updated efficacy data. The company subsequently resubmitted the sBLA for patients with papillary-only NMIBC, including updated long-term follow-up data, and the Agency has acknowledged receipt of the filing.

The sBLA aims to address the unmet need for patients with papillary-only NMIBC, supported by what is believed to be the longest duration of follow-up and bladder preservation data in this patient population. Approximately 60,000 people are diagnosed with NMIBC annually in the U.S., with approximately 70% presenting with papillary (Ta) disease. The long-term safety and efficacy results for ANKTIVA plus BCG in BCG-unresponsive non-muscle invasive bladder cancer with papillary tumors have been published in The Journal of Urology.

The sBLA submission for BCG-unresponsive NMIBC papillary disease 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. The study met its primary endpoint with a 12-month disease-free survival rate of 58%.

The mechanism of action of ANKTIVA's IL-15 superagonist activity was affirmed by the FDA's approval of ANKTIVA in 2024 for BCG-unresponsive NMIBC with carcinoma in situ (CIS), with or without papillary tumors.

ImmunityBio held productive regulatory discussions with the Saudi Food and Drug Authority in Riyadh convened under the Saudi-USA Biotech Alliance, hosted by the Ministry of Investment of Saudi Arabia. The SFDA encouraged the company to submit a regulatory package for ImmunityBio's recombinant BCG (rBCG) to expand BCG access for Saudi Arabia to overcome the BCG shortage. The Company expects to submit the rBCG regulatory package to the SFDA within the coming weeks.

ImmunityBio's rBCG is manufactured by the Serum Institute of India, the world's largest vaccine manufacturer by number of doses produced, under an exclusive global licensing and supply arrangement announced in May 2024. The Serum Institute's manufacturing facility in Pune, India, has been inspected and certified by multiple global regulatory authorities, including the World Health Organization, the European Medicines Agency, and the U.S. Food and Drug Administration.

In the United States, the FDA has authorized an Expanded Access Program for rBCG to address the ongoing national shortage of TICE BCG. The program is now active at 57 urology centers across the country, with over 500 patients enrolled and thousands of doses of rBCG administered to date. Phase 1/2 clinical trials conducted in Europe, rBCG demonstrated potent immunogenicity with CD8+ and CD4+ T cell stimulation and an improved safety profile compared to standard BCG, with fewer adverse events compared to earlier formulations.

ImmunityBio and the SFDA initiated discussions for the expansion of ANKTIVA plus checkpoint inhibitors into multiple tumor types in patients who have relapsed following checkpoint inhibitor therapy. These discussions build on the accelerated approval granted by the SFDA in January 2026 for ANKTIVA in combination with immune checkpoint inhibitors for adult patients with metastatic non-small cell lung cancer whose disease has progressed following standard of care therapy including checkpoint inhibitors, the first approval of this indication anywhere in the world and the first approval for subcutaneous administration of ANKTIVA plus a checkpoint inhibitor.

The SFDA has now approved ANKTIVA across two indications in Saudi Arabia: BCG unresponsive non muscle invasive bladder cancer and metastatic NSCLC in combination with checkpoint inhibitors. The QUILT-3.055 basket trial has demonstrated that ANKTIVA rescues checkpoint inhibitor activity across multiple tumor types, including NSCLC, urothelial, head and neck, melanoma, renal, gastric, and cervical cancers, with a median overall survival of 14.1 months in CPI relapsed NSCLC patients.

Based on the IL-15 mechanism of action and results from the QUILT 3.055 study, 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, including checkpoint inhibitor treatment. In this setting, multiple randomized studies of investigational agents compared with docetaxel chemotherapy have failed to demonstrate improved outcomes, underscoring the significant unmet need among patients who experience relapse or progression after checkpoint inhibitor therapy.