regulatory
confidence high
sentiment positive
materiality 0.75
ImmunityBio gets UAE marketing authorization for ANKTIVA in bladder and lung cancers
ImmunityBio, Inc.
- UAE approved ANKTIVA for BCG-unresponsive NMIBC (CIS and papillary) and metastatic NSCLC after checkpoint failure.
- NMIBC CIS cohort (N=100): 71% complete response rate; median DoR 26.6 months, with responses beyond 54 months.
- Papillary-only cohort (N=80): 12-month disease-free survival 58.2%; 83.1% cystectomy-free at 36 months.
- NSCLC checkpoint-refractory (N=79): median OS 14.6 months; 16.2 months in patients with ALC ≥1,000.
- Authorization expands ANKTIVA's global regulatory footprint to 34 countries; validity through July 2031.