ImmunityBio (NASDAQ:IBRX) shares climbed 7.5% on Thursday after the company announced that the United Arab Emirates had granted marketing approval for ANKTIVA in two cancer indications, further expanding the therapy’s international regulatory reach.
The latest authorization broadens the drug’s availability and marks another milestone in ImmunityBio’s global commercialization strategy.
UAE Clears ANKTIVA for Two Cancer Indications
The Emirates Drug Establishment approved ANKTIVA 0.4 mg in combination with Bacillus Calmette-Guérin (BCG) for the treatment of adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).
The regulator also authorized ANKTIVA 1.2 mg in combination with immune checkpoint inhibitors for adult patients with metastatic non-small cell lung cancer (NSCLC).
With the UAE approval, ANKTIVA is now authorized in 34 countries and has secured regulatory clearance across five jurisdictions.
According to the company, the NMIBC approval is the first worldwide to cover the full range of BCG-unresponsive disease, including carcinoma in situ (CIS) with or without papillary tumors, as well as papillary disease without CIS.
Clinical Trial Results Supported the Approval
The authorization for non-muscle invasive bladder cancer was supported by data from the QUILT-3.032 clinical trial.
Among 100 patients with carcinoma in situ, treatment with ANKTIVA plus BCG achieved a complete response rate of 71%, while the duration of complete response extended beyond 54 months.
In a separate group of 80 patients with papillary-only disease, the 12-month disease-free survival rate reached 58.2%, while 83% of patients remained free from cystectomy after 36 months.
Lung Cancer Approval Based on QUILT-3.055 Study
For metastatic non-small cell lung cancer, ANKTIVA combined with an immune checkpoint inhibitor was approved for adults whose disease progressed despite standard treatments, including prior checkpoint inhibitor therapy.
The authorization was supported by results from the QUILT-3.055 trial, which reported a median overall survival of 14.6 months among 79 patients with checkpoint-refractory advanced NSCLC.
ImmunityBio noted that patients with BCG-unresponsive NMIBC face a significant risk of disease progression, with radical cystectomy historically serving as the standard treatment option after BCG therapy fails.
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