On November 9, 2026 ImmunityBio, Inc. (NASDAQ: IBRX) ("ImmunityBio") and Rafa Laboratories Ltd. (TASE: RAFA) ("Rafa") reported that the Israeli Ministry of Health (MoH) has granted approval for ANKTIVA (nogapendekin alfa inbakicept), indicated in combination with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. The approval was granted four months after submission under an accelerated review pathway. The registration license is expected within the coming weeks.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the distribution agreement between the companies, Rafa will be the exclusive commercialization partner for ANKTIVA in Israel, bringing together ImmunityBio’s innovative immunotherapy platform and Rafa’s established capabilities and presence in the Israeli healthcare market.

ANKTIVA is a first-in-class IL-15 receptor agonist immunotherapy designed to activate natural killer (NK) cells and T cells and drive their proliferation. In the United States, ANKTIVA was approved by the U.S. Food and Drug Administration in April 2024 in combination with BCG for BCG-unresponsive NMIBC with CIS, with or without papillary tumors. The FDA subsequently expanded the label for ANKTIVA in combination with BCG to include adults with BCG-unresponsive NMIBC, including those with papillary-only disease.

"Patients with BCG-unresponsive bladder cancer have historically faced limited treatment options, underscoring the urgent need for new therapeutic approaches," said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Medical and Scientific Officer of ImmunityBio. "We developed ANKTIVA based on the understanding that the immune system has the innate ability to recognize and destroy cancer, and that activating natural killer cells and memory T cells is fundamental to sustaining an immune response. This approval in Israel represents another important step in our mission to expand global access to a chemotherapy-free immunotherapy combination for patients facing this challenging disease. We look forward to working with Israel’s physicians to bring this innovative treatment option to patients in need."

"The approval of ANKTIVA in Israel represents an important milestone for patients with non-muscle invasive bladder cancer and reflects Rafa’s commitment to bringing meaningful therapeutic innovation to patients in Israel," said Iddo Leshem, CEO of Rafa Laboratories. "We are proud to partner with ImmunityBio to make this novel immunotherapy available locally and to combine their scientific innovation with Rafa’s experience and capabilities in the Israeli healthcare system."

"Expanding access to ANKTIVA internationally is a key part of our mission to transform cancer care by harnessing the power of the immune system," said Richard Adcock, President and CEO of ImmunityBio. "Rafa’s strong presence and experience in the Israeli healthcare market make them an excellent partner to bring ANKTIVA to eligible patients in Israel. This approval represents another step in expanding access to ANKTIVA for patients with BCG-unresponsive NMIBC around the world."

Unmet Medical Need in Israel

Bladder cancer is a significant public health concern in Israel. It has been reported as the fourth most common cancer among Israeli men,¹ and 1,775 patients were diagnosed in 2018, more than 80% of them men.² That same year, 401 deaths from bladder cancer were recorded.² Over the past two decades, the incidence of in situ bladder cancer has increased, while the incidence of invasive bladder cancer has declined.¹ For patients with BCG-unresponsive high-risk NMIBC, radical cystectomy is the standard treatment recommended by the European Association of Urology guidelines.³ It is a major surgical procedure and is not suitable for every patient. Bladder-preserving treatment options for this population therefore remain an area of high unmet medical need.

About ANKTIVA (nogapendekin alfa inbakicept)

The interleukin-15 (IL-15) cytokine 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. ANKTIVA is a first-in-class IL-15 receptor 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.

IMPORTANT U.S. SAFETY INFORMATION

INDICATION AND USAGE: ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated in combination with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC).

WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with BCG-unresponsive NMIBC have evidence of high-grade disease after a second induction course of ANKTIVA with BCG, reconsider cystectomy.

DOSAGE AND ADMINISTRATION: For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes.

ADVERSE REACTIONS: The most common (≥15%) adverse reactions, including laboratory test abnormalities, are increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills, and pyrexia.

(Press release, ImmunityBio, NOV 9, 2026, View Source [SID1234674475])