- \n
- \nANKTIVA approved for patients with certain indications of non-muscle invasive bladder cancer and non-small cell lung cancer<\/p>\n<\/li>\n
- \nCommercial availability achieved within two months of announcing MENA partnership with Biopharma and Cigalah Healthcare<\/p>\n<\/li>\n
- \nFirst patients to be dosed have been identified and will soon receive initial ANKTIVA treatment<\/p>\n<\/li>\n<\/ul>\n
CULVER CITY, Calif.–(BUSINESS WIRE<\/a>)–
\nImmunityBio, Inc. (NASDAQ: IBRX<\/a>), a commercial-stage immunotherapy company, today announced that ANKTIVA\u00ae (nogapendekin alfa inbakicept) is now commercially available in Saudi Arabia. Initial patients have been identified for treatment across both approved bladder and lung cancer indications in the Kingdom:<\/p>\n- \n
- \nIn combination with Bacillus Calmette-Gu\u00e9rin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS), with or without papillary disease; and<\/p>\n<\/li>\n
- \nIn combination with an immune checkpoint inhibitor for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC), as authorized by the Saudi Food and Drug Authority (SFDA)<\/p>\n<\/li>\n<\/ul>\n
\nANKTIVA is being distributed through ImmunityBio\u2019s partnerships with Biopharma and Cigalah Healthcare, leading healthcare distribution companies in the Middle East, with support from the company\u2019s wholly owned subsidiary in Saudi Arabia.<\/p>\n
\n\u201cThanks to our strategic partnership with Biopharma and Cigalah Healthcare, and despite a fluid situation in the region, we have been able to bring this innovative cancer treatment to patients ahead of the deadline we announced in February,\u201d said Richard Adcock, President and CEO of ImmunityBio. \u201cWe continue to work with the same level of diligence and commitment to expand access to ANKTIVA for eligible patients across the Middle East and North Africa.\u201d<\/p>\n
\nThe Middle East and North Africa (MENA) region faces one of the most rapidly growing burdens of cancer globally, including bladder and lung cancers, underscoring the need for additional treatment options. Lung cancer today is among the most common cancers in Saudi Arabia, while the incidence of bladder cancer is elevated in several countries across the region. 1 2<\/sup><\/p>\n
\n\u201cWe are pleased to support the introduction of this immunotherapy to physicians and their patients in Saudi Arabia,\u201d said Tamer Eissa, General Manager, Biopharma. \u201cWe look forward to expanding access across the region.\u201d<\/p>\n
\n\u201cThis milestone represents an important step in expanding access to ANKTIVA for patients in Saudi Arabia,\u201d said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. \u201cWe are encouraged by the growing body of clinical data and experience supporting its use across multiple indications and remain committed to working with physicians to bring this immunotherapy to appropriate patients in need around the globe.\u201d<\/p>\n
\nANKTIVA received U.S. Food and Drug Administration approval in April 2024 in combination with BCG for the treatment of BCG-unresponsive NMIBC CIS, with or without papillary tumors. It has subsequently received regulatory authorizations in multiple regions, including the United Kingdom (MHRA, July 2025), the European Union (European Commission, February 2026), Macau Special Administration Region of China (ISAF, March 2026), and Saudi Arabia (SFDA, January 2026); in addition, the SFDA approved ANKTIVA in combination with a checkpoint inhibitor for the treatment of metastatic non-small cell lung cancer.<\/p>\n
Saudi Arabia Indication and Usage<\/b><\/p>\n
\nBCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ:<\/p>\n
\nANKTIVA in combination with Bacillus Calmette-Gu\u00e9rin (BCG) is indicated for the treatment of adult patients with high-risk BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) of carcinoma in situ (CIS) with or without papillary disease.<\/p>\n
\nNon-small cell lung cancer (NSCLC):<\/p>\n
\nANKTIVA is indicated in combination with immune checkpoint inhibitors for the treatment of adult patients with metastatic NSCLC with disease progression on or after standard of care (immune checkpoint inhibitors alone or in combination with chemotherapy).<\/p>\n
\nThis indication is approved under accelerated approval based on the increase of ALC associated with overall survival in single arm study. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory clinical trials.<\/p>\n
U.S. IMPORTANT SAFETY INFORMATION<\/b><\/p>\n
INDICATION AND USAGE:<\/b> ANKTIVA\u00ae<\/sup> is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Gu\u00e9rin (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.<\/p>\n
WARNINGS AND PRECAUTIONS:<\/b> 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 CIS do not have a complete response to treatment after a second induction course of ANKTIVA\u00ae<\/sup> with BCG, reconsider cystectomy.<\/p>\n
DOSAGE AND ADMINISTRATION:<\/b> For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes.<\/p>\n
\nPlease see the complete Indication and Important Safety Information and Prescribing Information for ANKTIVA\u00ae<\/sup> at Anktiva.com<\/a>.<\/p>\n
About ImmunityBio<\/b><\/p>\n
\nImmunityBio, Inc. is a biotechnology company focused on innovating, developing, and commercializing next-generation immunotherapies designed to activate the patient\u2019s immune system and deliver durable protection against cancer and infectious diseases. Our approach harnesses both the adaptive and innate immune systems with the goal of restoring immune function and generating lasting immunological memory in patients. At the core of our strategy is the Cancer BioShield\u2122<\/sup> platform, which is designed to stimulate critical lymphocytes, including natural killer (NK) cells, cytotoxic T cells, and memory T cells via our proprietary IL-15 superagonist. Our Cancer BioShield platform is anchored by this antibody-cytokine fusion protein and is complemented by an investigational portfolio that includes adenovirus-vectored vaccines, allogeneic (off-the-shelf) and autologous NK-cell therapies, and additional immunomodulators intended to promote immunogenic cell death and support durable immune responses while potentially reducing reliance on high-dose chemo-radiation therapy. For more information, visit ImmunityBio.com<\/a> and connect with us on X<\/a> (Twitter), Facebook<\/a>, LinkedIn<\/a>, and Instagram<\/a>.<\/p>\n
About Cigalah Healthcare:<\/b><\/p>\n
\nBased in Jeddah, Cigalah Healthcare is a leading pharmaceutical and healthcare distribution company and sole agent for many multinational pharmaceutical, herbal, health care, and cosmetic companies in Saudi Arabia and some other Gulf countries. Established in 1987, Cigalah Healthcare is the fastest growing health care distributor in Saudi Arabia and the Middle East.<\/p>\n
About Biopharma Middle East and Africa:<\/b><\/p>\n
\nBiopharma-MEA is a regional Middle East company, headquartered in Dubai, United Arab Emirates, with offices across the Middle East countries. Since 2007, Biopharma has provided commercialization services for international biopharmaceutical companies throughout the Middle East focusing on rare and serious disease therapies.<\/p>\n
\nReferences:<\/p>\n
- \n
- \nSaudi national lung cancer epidemiology from the Saudi Cancer Registry, 2015\u20132020<\/i> (AlOmar & AlAbdulKader, J Epidemiol Glob Health<\/i>, 2025).<\/p>\n<\/li>\n
- \nBased on 2018 GLOBOCAN cancer incidence data reported in Cancer incidence and mortality estimates in Arab countries<\/i> (medRxiv, 2022).<\/p>\n<\/li>\n<\/ol>\n
Forward Looking Statements<\/b><\/p>\n
\nThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, without limitation, statements regarding the commercialization and distribution of ANKTIVA in Saudi Arabia and the broader MENA region, the identification and treatment of patients with BCG-unresponsive NMIBC CIS and metastatic non-small cell lung cancer (NSCLC), the expansion of access to ANKTIVA across the Middle East and North Africa, the potential for continued regulatory approvals in additional markets, and the therapeutic potential of ANKTIVA across multiple indications. These statements are based on the Company’s current expectations, beliefs, assumptions, and plans and involve significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such forward-looking statements.<\/p>\n
\nSuch risks and uncertainties include, among others: risks related to the successful commercialization of ANKTIVA in Saudi Arabia and other markets, including the ability to build and maintain adequate supply chains and distribution networks; the Company’s dependence on its partnership with Biopharma and Cigalah Healthcare for distribution in the MENA region; the risk that regional instability or other geopolitical factors could disrupt commercial operations; the Company’s ability to achieve and maintain adequate levels of reimbursement for ANKTIVA; the risk that safety or efficacy data from ongoing or future clinical trials may not support continued approval or commercial success; competition from other therapies; manufacturing risks and the ability to maintain adequate supply of product; and the Company’s ability to obtain and maintain intellectual property protection for ANKTIVA.<\/p>\n
\nMore details about these and other risks that may impact ImmunityBio’s business are described under the heading “Risk Factors” in the Company’s Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 23, 2026, and in subsequent filings made by ImmunityBio with the SEC, which are available on the SEC’s website at www.sec.gov<\/a>.<\/p>\n
\nImmunityBio cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. ImmunityBio does not undertake any duty to update any forward-looking statement or other information in this press release, except to the extent required by law.<\/p>\n
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View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20260421405182\/en\/<\/a><\/span><\/p>\n
Investors
\n<\/b>
Hemanth Ramaprakash, PhD, MBA
\n<\/b>
ImmunityBio, Inc.
\n<\/b>
+1 858-746-9289
\n
Hemanth.Ramaprakash@ImmunityBio.com<\/a><\/p>\nMedia
\n<\/b>
Sarah Singleton
\n<\/b>
ImmunityBio, Inc.
\n<\/b>
+1 415-290-8045
\n
Sarah.Singleton@ImmunityBio.com<\/a><\/p>\nKEYWORDS:<\/b> California United States Saudi Arabia North America Middle East<\/p>\n
INDUSTRY KEYWORDS:<\/b> Biotechnology Pharmaceutical Health Oncology<\/p>\n
- \nBased on 2018 GLOBOCAN cancer incidence data reported in Cancer incidence and mortality estimates in Arab countries<\/i> (medRxiv, 2022).<\/p>\n<\/li>\n<\/ol>\n
- \nSaudi national lung cancer epidemiology from the Saudi Cancer Registry, 2015\u20132020<\/i> (AlOmar & AlAbdulKader, J Epidemiol Glob Health<\/i>, 2025).<\/p>\n<\/li>\n
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