ImmunityBio secures UAE marketing authorisation for ANKTIVA in bladder and lung cancers
On 29 July 2026, ImmunityBio (Nasdaq: IBRX) announced that the United Arab Emirates' Emirates Drug Establishment (EDE) has granted marketing authorisation for ANKTIVA (nogapendekin alfa inbakicept) across two cancer indications, first registered on 24 July 2026 and valid through July 2031.
The EDE authorised ANKTIVA 0.4 mg intravesical instillation in combination with Bacillus Calmette-Guérin (BCG) for adults with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) — including carcinoma in situ (CIS) with or without papillary tumours, and papillary-only disease. ImmunityBio said this is the first authorisation worldwide to span the full spectrum of BCG-unresponsive NMIBC. Trial data cited a 71% complete response rate across 100 CIS patients.
The EDE also cleared a fixed 1 mg subcutaneous dose of ANKTIVA given once every 21 days in combination with immune checkpoint inhibitors for adults with metastatic non-small cell lung cancer (NSCLC) who have progressed on standard-of-care therapy, where median overall survival reached 14.6 months. ANKTIVA is an IL-15 receptor agonist; the approvals extend its international footprint following earlier Saudi FDA accelerated approvals in January 2026.