The Emirates Drug Establishment (EDE) in the United Arab Emirates on Thursday approved ImmunityBio Inc.’s (NASDAQ: IBRX ) immunotherapy drug, ANKTIVA.
The regulatory action covers two distinct indications , making the UAE the fifth jurisdiction worldwide to approve the treatment and expanding its global footprint to 34 countries.
Broadest NMIBC Approval Globally
The UAE’s authorization for non-muscle invasive bladder cancer (NMIBC) represents the most comprehensive approval for ANKTIVA to date.
It permits a 0.4 mg intravesical dose combined with BCG for adult patients with BCG-unresponsive NMIBC .
Notably, this is the first authorization worldwide to cover the entire disease spectrum, encompassing carcinoma in situ (CIS) and papillary disease, whether occurring together or independently .
Historically, patients failing BCG therapy faced high progression risks and often relied on radical cystectomy as the standard alternative.
Clinical evidence from the QUILT-3.032 trial showed a 71% complete response rate in the CIS cohort, extending beyond 54 months.
In the papillary-only cohort, patients achieved a 58.2% disease-free survival rate at 12 months and an 83% cystectomy-free rate at 36 months.
Addressing Metastatic NSCLC Needs
Additionally, the EDE authorized a 1.2 mg subcutaneous dose of ANKTIVA in combination with immune checkpoint inhibitors for adults with metastatic non-small cell lung cancer (NSCLC).
The approval applies to patients whose disease progressed on or after standard treatments, including checkpoint inhibitor failure.
Checkpoint inhibitor resistance remains a significant hurdle in NSCLC, traditionally resulting in poor survival outcomes .
By activating memory T cells and natural killer cells, ANKTIVA is designed to restore anti-tumor immunity.
In the QUILT-3.055 trial, checkpoint-refractory advanced NSCLC patients recorded a median overall survival of 14.6 months, providing a vital new therapy option for those with limited alternatives.
IBRX Stock Price Activity: ImmunityBio shares were up 5.49% at $7.20 at the time of publication Thursday, according to Benzinga Pro data .
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