ImmunityBio said the United Arab Emirates has granted marketing authorization for ANKTIVA, expanding the cancer therapy’s regulatory reach in the region. According to the company, the approval was issued by the Emirates Drug Establishment and covers both bladder cancer indications and metastatic non-small cell lung cancer.
Based on the approved UAE prescribing information referenced in the announcement, ANKTIVA is indicated with BCG for adults with BCG-unresponsive non-muscle invasive bladder cancer involving carcinoma in situ, with or without papillary disease. The company also described the authorization as covering papillary disease within this bladder cancer setting.
The announcement further stated that ANKTIVA received UAE marketing authorization for metastatic non-small cell lung cancer. While the trimmed release does not include the full treatment details for the lung cancer use, the decision signals a broader oncology label in the UAE than a single disease setting.
For ImmunityBio, the authorization marks another regulatory milestone for ANKTIVA and could support commercial expansion in the Gulf market. The approval also highlights the UAE’s role in bringing newer oncology treatments to patients with difficult-to-treat cancers, including BCG-unresponsive bladder cancer and advanced lung cancer.
