ImmunityBio wins UAE authorization for ANKTIVA in bladder cancer and lung cancer

ImmunityBio, Inc. announced on July 29, 2026 that the Emirates Drug Establishment of the United Arab Emirates granted Marketing Authorization for ANKTIVA (nogapendekin alfa inbakicept) across two indications.¹ This makes the UAE the fifth regulatory jurisdiction to authorize ANKTIVA, bringing its total authorized countries to 34.¹

The authorization covers two distinct formulations. ANKTIVA 0.4 mg/0.4 mL, given by intravesical instillation, is authorized in combination with Bacillus Calmette-Guérin (BCG) for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), while ANKTIVA 1.2 mg/0.6 mL, given subcutaneously, is authorized in combination with immune checkpoint inhibitors for metastatic non-small cell lung cancer (NSCLC).¹ The company said this is the first worldwide authorization to span the full spectrum of BCG-unresponsive disease, covering carcinoma in situ with or without papillary tumors, as well as papillary disease alone.¹

On the bladder cancer data from trial QUILT-3.032, in the CIS cohort of 100 patients, ANKTIVA plus BCG achieved a complete response rate of 71% (95% CI: 61, 80).¹ In the papillary-only cohort of 80 patients, the 12-month disease-free survival rate was 58.2% (95% CI: 46.6, 68.2), with median disease-free survival of 25.3 months, and 83.1% of patients avoided cystectomy at 36 months.¹

For the lung cancer indication, data came from QUILT-3.055. The Phase 2 study enrolled 79 patients with advanced NSCLC who had progressed on prior checkpoint inhibitor therapy, and median overall survival was 14.6 months (95% CI: 12.0, 19.5).¹ Among the 77% of patients who reached an absolute lymphocyte count of at least 1,000 cells/µL, median overall survival rose to 16.2 months (95% CI: 13.8, 22.0).¹

The EDE issued the marketing authorizations with first registration in July 2026, valid through July 2031.¹ ImmunityBio is the Marketing Authorization Holder, with Modern Pharmaceutical Company serving as its local agent in the UAE.¹