ImmunityBio's stock jumped nearly 6% in early trading, reversing earlier losses following regulatory clearance in the UAE for ANKTIVA's use in bladder and lung cancers. This marks the broadest approval the treatment has secured so far, expanding its reach across critical patient groups with limited options.
UAE Greenlights ANKTIVA for Multiple Cancer Types
The Emirates Drug Establishment gave the nod to ANKTIVA combined with BCG for adults with BCG-unresponsive non-muscle invasive bladder cancer. This approval covers a full spectrum including carcinoma in situ, mixed tumors, and papillary-only disease without carcinoma in situ, a first in one decision.
also ANKTIVA paired with immune checkpoint inhibitors received authorization for metastatic non-small cell lung cancer patients who failed prior standard therapies. Those with actionable mutations must have progressed after approved targeted treatments before becoming eligible.
The UAE becomes the fifth regulatory region endorsing ANKTIVA, which now holds approval across 34 countries globally. This positions ImmunityBio well in two tough arenas with desperate need for effective therapies.
Strong Data Underpin Expanded Coverage for Bladder Cancer
The bladder cancer approval primarily came from multicenter QUILT-3.032 trial results showing a 71% complete response rate in patients with carcinoma in situ receiving ANKTIVA and BCG. Median duration of response was 26.6 months, with 66% maintaining complete response at 12 months and 42% still responding at two years.
In the papillary-only group, the disease control rate approached 58%, reinforcing broad applicability. This solid efficacy offers hope for patients facing non-muscle invasive bladder cancer without good alternatives, as well as those battling advanced lung cancer.
This article is for informational purposes and does not constitute financial advice.
