RegulatoryJul 30, 2026, 05:22 PM
ImmunityBio ANKTIVA Gets UAE Approval for Bladder & Lung Cancers
AI Summary
ImmunityBio announced that the Emirates Drug Establishment (EDE) of the UAE granted marketing authorization for its drug ANKTIVA® for two indications: BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) and metastatic non-small cell lung cancer (NSCLC). This approval expands ANKTIVA's global regulatory footprint to 34 countries and marks the broadest approval to date, covering the full spectrum of BCG-unresponsive NMIBC. The authorization for NSCLC is for patients who progressed on checkpoint inhibitors and chemotherapy.
Key Highlights
- UAE granted marketing authorization for ANKTIVA across two indications.
- Expands ANKTIVA's global regulatory footprint to 34 countries.
- NMIBC approval is first worldwide to span full spectrum of BCG-unresponsive disease.
- NMIBC CIS cohort (N=100) showed 71% complete response rate.
- NMIBC papillary-only cohort (N=80) had 58.2% 12-month disease-free survival.
- NSCLC (N=79) showed median overall survival of 14.6 months.
- UAE is the fifth regulatory jurisdiction to authorize ANKTIVA.
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