ImmunityBio, Inc. (NASDAQ: IBRX) announced that the Emirates Drug Establishment (EDE) of the United Arab Emirates has granted marketing authorization for ANKTIVA® (nogapendekin alfa inbakicept) across two cancer indications, according to a company press release.

The authorization covers ANKTIVA 0.4 mg in combination with BCG for adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), and ANKTIVA 1.2 mg in combination with immune checkpoint inhibitors for adult patients with metastatic non-small cell lung cancer (NSCLC). The UAE is the fifth regulatory jurisdiction to authorize ANKTIVA, following the United States, the United Kingdom, the Kingdom of Saudi Arabia, and the European Union, expanding its authorization to 34 countries.

The company said the NMIBC authorization covers the full spectrum of BCG-unresponsive disease, including carcinoma in situ (CIS) with or without papillary tumors, and papillary disease alone without CIS — a scope it describes as a first worldwide.

Clinical data supporting the NMIBC authorization came from the QUILT-3.032 trial. In the CIS cohort (N=100), ANKTIVA plus BCG produced a complete response rate of 71% (95% CI: 61, 80), with response duration extending beyond 54 months. In the papillary-only cohort (N=80), the 12-month disease-free survival rate was 58.2% (95% CI: 46.6, 68.2), and 83.1% of patients avoided cystectomy at 36 months.

The NSCLC authorization is supported by the Phase 2 QUILT-3.055 trial (N=79), in which median overall survival was 14.6 months (95% CI: 12.0, 19.5) in checkpoint-refractory patients. Among patients achieving an absolute lymphocyte count of at least 1,000 cells/µL, median overall survival was 16.2 months (95% CI: 13.8, 22.0).

Both authorizations carry a validity period from July 2026 through July 2031. Modern Pharmaceutical Company will serve as the local agent in the UAE.