CULVER CITY, Calif., July 29, 2026
ImmunityBio announced that the Emirates Drug Establishment (EDE) has granted Marketing Authorization for ANKTIVA® (nogapendekin alfa inbakicept) across two oncology indications in the United Arab Emirates (UAE). The approvals cover ANKTIVA 0.4 mg in combination with Bacillus Calmette-Guérin (BCG) for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) and ANKTIVA 1.2 mg in combination with immune checkpoint inhibitors for metastatic non-small cell lung cancer (NSCLC). This authorization expands ANKTIVA’s global regulatory footprint to 34 countries, making the UAE the fifth regulatory jurisdiction to approve the therapy. Notably, the bladder cancer authorization is the world’s first to include the full spectrum of BCG-unresponsive NMIBC, covering carcinoma in situ (CIS) with or without papillary tumors, as well as papillary disease alone, addressing a major unmet medical need for patients seeking alternatives to radical cystectomy.
World’s First Broad NMIBC Approval Expands Treatment Options
The UAE approval marks a significant milestone for ImmunityBio, as ANKTIVA plus BCG becomes the first immunotherapy authorized worldwide for patients across the complete range of BCG-unresponsive NMIBC. Clinical evidence from the QUILT-3.032 registrational trial demonstrated a 71% complete response rate in patients with CIS with or without papillary tumors, with responses lasting beyond 54 months in some patients. In the papillary-only cohort, the therapy achieved a 58.2% disease-free survival rate at 12 months, while 83% of patients remained cystectomy-free after 36 months. The treatment also maintained a favorable safety profile, with most treatment-related adverse events classified as Grade 1 or Grade 2, and no reported Grade 4 or Grade 5 treatment-related toxicities. These findings support ANKTIVA as a promising bladder-preserving immunotherapy for patients who have limited treatment options after failing BCG therapy.
ANKTIVA Also Authorized for Checkpoint-Refractory Metastatic NSCLC
In addition to bladder cancer, the EDE approved ANKTIVA in combination with immune checkpoint inhibitors for adult patients with metastatic NSCLC whose disease has progressed after standard treatments, including prior checkpoint inhibitor therapy. The authorization is supported by results from the Phase 2 QUILT-3.055 trial, which enrolled 79 patients with advanced checkpoint-refractory NSCLC. The study reported a median overall survival of 14.6 months, while patients achieving an absolute lymphocyte count of at least 1,000 cells/µL experienced an improved median overall survival of 16.2 months. By activating natural killer (NK) cells, CD8+ killer T cells, and memory T cells, ANKTIVA is designed to restore anti-tumor immunity in patients whose tumors have become resistant to conventional checkpoint inhibitors. The dual approval highlights the therapy’s potential to address challenging cancers through its IL-15 receptor agonist mechanism.
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Global Expansion Strengthens ImmunityBio’s Oncology Strategy
The UAE authorization further reinforces ImmunityBio’s international commercialization strategy by expanding access to ANKTIVA across both bladder cancer and lung cancer indications. Company Founder and Executive Chairman Dr. Patrick Soon-Shiong described the approval as a major advancement for immunotherapy, emphasizing its ability to stimulate NK cells, cytotoxic T cells, and memory T cells to generate durable anti-cancer responses. President and CEO Richard Adcock noted that the approvals, based on the same clinical data submitted to the U.S. FDA, position the company to broaden patient access throughout the Gulf region in partnership with Modern Pharmaceutical Company. With regulatory approvals now spanning 34 countries, ImmunityBio continues to strengthen the global presence of ANKTIVA while advancing next-generation immunotherapies for patients with difficult-to-treat cancers.
Source: ImmunityBio press release
