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.