ImmunityBio announced it has received marketing authorization from the United Arab Emirates (UAE) Emirates Drug Establishment (EDE) for its drug ANKTIVA® for two distinct cancer indications. The approval expands the drug's global regulatory footprint to 34 countries.
Key Details
- Approved Indications: The authorization covers 1) BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) and/or papillary tumors, and 2) Metastatic non-small cell lung cancer (NSCLC) in patients who have failed checkpoint inhibitors.
- Bladder Cancer (NMIBC) Efficacy: In clinical trials, ANKTIVA plus BCG demonstrated a 71% complete response rate in the CIS cohort, with response duration extending beyond 54 months. The papillary-only cohort showed a 58.2% disease-free survival rate at 12 months.
- Lung Cancer (NSCLC) Efficacy: For checkpoint-refractory NSCLC, ANKTIVA plus a checkpoint inhibitor showed a median overall survival of 14.6 months.
- Authorization Term: The marketing authorization is effective from July 2026 and is valid for five years, through July 2031.