ImmunityBio (NASDAQ:IBRX) announced Wednesday that the Saudi Food and Drug Authority (SFDA) has approved ANKTIVA® (nogapendekin alfa inbakicept) for the treatment of non-muscle invasive bladder cancer (NMIBC).
The decision marks a significant milestone for the California-based immunotherapy firm as it establishes a commercial foothold in the Middle East and North Africa (MENA) region.
The approval specifically covers the use of ANKTIVA in combination with Bacillus Calmette-Guérin (BCG) for adult patients with BCG-unresponsive NMIBC carcinoma in situ.
Saudi Arabia now joins the United States, the United Kingdom, and the European Union in authorizing the first-in-class IL-15 receptor agonist, which works by activating natural killer (NK) cells and T cells to overcome tumor resistance.
To support the launch, ImmunityBio plans to open a regional office in Saudi Arabia, serving as a strategic base for operations across the MENA region.
The company has tapped Biopharma Cigalah as its exclusive commercial and distribution partner. Cigalah, a major healthcare distributor in the Kingdom, will provide the cold-chain infrastructure and market-access capabilities necessary to deploy the therapy across specialized oncology centers.
While the current approval targets patients who have failed prior treatment, ImmunityBio is rapidly advancing toward the much larger "front-line" market.
The company reported that its randomized QUILT-2.005 trial—comparing ANKTIVA plus BCG to BCG alone in treatment-naïve patients—is progressing ahead of schedule.
The Saudi approval also coincided with a secondary announcement that the SFDA has granted accelerated approval for ANKTIVA in combination with checkpoint inhibitors for metastatic non-small cell lung cancer (NSCLC).
This dual-regulatory win propelled ImmunityBio shares up 6% in Wednesday morning trading, as investors reacted to the company's aggressive global commercialization strategy.