ImmunityBio Says Saudi FDA Encouraged rBCG Filing and ANKTIVA Expansion Talks

ImmunityBio said it held regulatory discussions with the Saudi Food and Drug Authority in Riyadh, and that the SFDA encouraged the company to submit a regulatory package for its recombinant BCG (rBCG) to expand BCG access in Saudi Arabia and address the ongoing global BCG shortage. The company also said it and the SFDA initiated discussions regarding expansion of ANKTIVA® (nogapendekin alfa inbakicept) in combination with checkpoint inhibitors to additional tumor types in the checkpoint inhibitor-relapsed population.

The company said it expects to submit the complete regulatory package for rBCG to the SFDA within the coming weeks. During the meeting, the SFDA encouraged ImmunityBio to submit a regulatory package for rBCG to support access to a new source of BCG in the Kingdom and help address the global BCG shortage that has affected bladder cancer patients worldwide including the Middle East.

ImmunityBio said its rBCG is manufactured by the Serum Institute of India 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 company said. The program is active at 57 urology centers across the country, with over 500 patients enrolled and thousands of doses of rBCG administered to date.

The company said Phase 1/2 clinical trials conducted in Europe showed that 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 also initiated discussions for expansion of ANKTIVA plus checkpoint inhibitors into multiple tumor types in patients who have relapsed following checkpoint inhibitor therapy. The company said these discussions build on 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 company said the QUILT-3.055 basket trial 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 checkpoint inhibitor-relapsed NSCLC patients. It also said the SFDA has approved ANKTIVA across two indications in Saudi Arabia: BCG-unresponsive non-muscle invasive bladder cancer and metastatic NSCLC in combination with checkpoint inhibitors.