The Emirates Drug Establishment (EDE) in the United Arab Emirates on Thursday approved ImmunityBio Inc.'s ImmunityBio (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 market data.