ImmunityBio Wins UAE Approval for Two ANKTIVA Indications
Papillary-only bladder-cancer patients had 58.2% disease-free survival at 12 months.
ImmunityBio (IBRX), the commercial-stage biotechnology company, won UAE marketing authorization for ANKTIVA in BCG-unresponsive non-muscle invasive bladder cancer and checkpoint-refractory metastatic non-small cell lung cancer.
The July authorization marked ANKTIVA’s first approved lung-cancer indication after earlier releases focused on U.S. commercialization and investigational NSCLC development. It also expanded the approved bladder-cancer population to papillary-only disease, which previously carried an NCCN recommendation but fell outside the narrower U.S. indication covering carcinoma in situ with or without papillary tumors.
The papillary-only authorization was supported by results from 80 patients. Median disease-free survival was 25.3 months, and the cystectomy-free rate was 83.1% at 36 months.
In checkpoint-refractory NSCLC, median overall survival was 14.6 months among 79 patients. Survival reached 16.2 months for patients whose mean on-treatment absolute lymphocyte counts were at least 1,000 cells per microliter, compared with 11.8 months below that threshold, with a hazard ratio of 0.52.
The new authorization left ImmunityBio’s commercial and regulatory reach unchanged at five jurisdictions spanning about 34 countries, the same footprint disclosed in the preceding quarter.
ImmunityBio provided no updated revenue, unit-sales, expense or liquidity figures with the announcement. Its preceding financial release reported first-quarter net product revenue of $44.2 million, up 168% from a year earlier and 15% sequentially, along with $380.9 million in cash and marketable securities.
The UAE decision broadened ANKTIVA’s approved uses across both tumor type and bladder-cancer presentation, leaving the pace of sales and geographic expansion to be measured in a subsequent financial update.