ImmunityBio receives UAE Marketing Authorization for ANKTIVA in BCG-unresponsive NMIBC (CIS and papillary disease) and mNSCLC

CAR-T Digest - August 2020

29 July 2026: ImmunityBio receives UAE Marketing Authorization for ANKTIVA in BCG-unresponsive NMIBC (CIS and papillary disease) and mNSCLC

ImmunityBio announced that the United Arab Emirates has granted marketing authorization for ANKTIVA, expanding its indications to include BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary disease, papillary disease alone without CIS, and metastatic non-small cell lung cancer
The NMIBC approval is supported by clinical data demonstrating a 71% complete response rate, a median duration of complete response of 26.6 months, and durable responses extending beyond 54 months in some patients. The metastatic NSCLC indication is based on evidence supporting ANKTIVA in combination with checkpoint inhibitors following progression on standard-of-care therapy
The UAE authorization addresses significant unmet needs by providing the first approval worldwide covering the full spectrum of BCG-unresponsive NMIBC-including papillary disease without CIS-while also expanding treatment options for patients with metastatic NSCLC who have limited therapeutic alternatives after standard therapy

ANKTIVA is a first-in-class IL-15 receptor agonist immunotherapy that activates and proliferates natural killer cells, CD8⁺ T cells, and memory T cells. In NMIBC, it is administered in combination with BCG to induce durable antitumor immune responses, while in metastatic NSCLC it is used with immune checkpoint inhibitors to enhance antitumor immunity
Strategically, the UAE approval strengthens ImmunityBio’s commercial expansion across the Middle East, broadens ANKTIVA’s global regulatory reach to 34 countries, and reinforces the company’s strategy of expanding the immunotherapy across multiple oncology indications while accelerating international commercialization

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