ImmunityBio Expands ANKTIVA Regulatory Footprint and Advances rBCG in Saudi Arabia
ImmunityBio received European Commission authorization for ANKTIVA in bladder cancer, expanding to 33 countries. The company held productive discussions with Saudi regulators on recombinant BCG and checkpoint inhibitor combinations.
ImmunityBio announced that the European Commission has granted conditional marketing authorization for ANKTIVA (nogapendekin alfa inbakicept) in combination with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS), with or without papillary tumors. ANKTIVA plus BCG, with a 71% complete response rate, is the first immunotherapy to receive marketing authorization in Europe for this indication, where no treatment was previously authorized for BCG-unresponsive disease.
The conditional marketing authorization enables commercial availability across all 27 European Union member states plus Iceland, Norway, and Liechtenstein, bringing the total number of countries where ANKTIVA is authorized to 33. ANKTIVA is now authorized across four regulatory jurisdictions: the United States (FDA, April 2024), United Kingdom (MHRA, July 2025), Kingdom of Saudi Arabia (SFDA, January 2026), and the European Union (EC, February 2026). The global regulatory footprint of 33 countries was built in under two years from initial FDA approval.
The conditional marketing authorization follows the positive opinion adopted by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on December 11, 2025, which recommended authorization based on its determination that the benefit of making ANKTIVA available to patients—with a complete response rate of 71%, a median duration of complete response of 26.6 months, and individual responses ranging up to 54+ months and ongoing—outweighs the risks associated with earlier access from a single-arm trial. As part of the conditional authorization, ImmunityBio will continue to follow up with trial participants and submit long-term safety and efficacy data to the EMA.
More than 150,000 patients are diagnosed annually with NMIBC across Europe. The European Commission's decision addresses an unmet medical need where the primary alternative for BCG-unresponsive patients has been radical cystectomy. With more than 80% of treated patients preserving their bladder through three years of follow-up, ANKTIVA represents a meaningful advance designed to strengthen the immune response and extend the durability of BCG.
ImmunityBio held productive regulatory discussions with the Saudi Food and Drug Authority (SFDA) 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 (WHO), the European Medicines Agency (EMA), and the U.S. Food and Drug Administration (FDA).
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 showed 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 inhibitor (CPI) 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 (NSCLC) 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 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. 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 Kingdom of Saudi Arabia remains the only jurisdiction where ANKTIVA has received authorization in two indications.