Saudi FDA Grants Accelerated Approval to ImmunityBio’s ANKTIVA®️ for Non-Muscle Invasive Bladder Cancer with Carcinoma In-Situ
ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced that the Saudi Food and Drug Authority (SFDA) has granted approval of ANKTIVA®️ (nogapendekin alfa inbakicept) plus Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ, with or without papillary disease. This regulatory action by the SFDA adds to the existing approvals in the United States and United Kingdom, as well as conditional approval in the European Union.
“We are pleased to bring ANKTIVA to Saudi patients with NMIBC, who otherwise have no viable options but life-altering surgery,” said Rich Adcock, Chief Executive Officer, ImmunityBio. “At ImmunityBio, we’re committed to using our innovative science to improve the health of people around the world, and we continue investing in research and clinical trials that we believe are essential to fulfilling that mission.”
ImmunityBio plans to open a regional office in the Kingdom of Saudi Arabia to support physicians and health systems across the Middle East and North Africa. The company will collaborate with Biopharma Cigalah as its commercial and distribution partner in the region. Founded in 2007, BioPharma Cigalah provides the commercial infrastructure and capabilities needed to support therapies for serious diseases and expand patient access throughout the Middle East and North Africa.
“The incidence of bladder and other cancers in the Middle East and North Africa is large and growing, demonstrating a significant unmet need for the kind of innovative treatments ImmunityBio is developing,” added Mr. Adcock. “We are pursuing approvals across the region to fill that need, as well as investing in a regional office in Saudi Arabia in order to support our expansion into these growing markets.”
The randomized QUILT-2.005 trial in BCG-naïve patients comparing BCG alone to BCG plus ANKTIVA is ongoing, and enrollment has exceeded expectations. Enrollment is on track to be completed by Q2 2026, with a potential BLA submission by year-end.
About ANKTIVA®️ (nogapendekin alfa inbakicept)
The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA®️ overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. A key component in the Company’s BioShield platform, ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA®️ mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.
