ImmunityBio Announces ANKTIVA® Is Now Available in Saudi Arabia for Bladder and Lung Cancer Patients; Market Entry Achieved Within Two Months of MENA Partnership
ImmunityBio Announces ANKTIVA® Is Now Available in Saudi Arabia for Bladder and Lung Cancer Patients; Market Entry Achieved Within Two Months of MENA Partnership
A form of bladder cancer that is confined to the inner lining of the bladder and has not grown into the deeper muscle layer; think of it like a stain on wallpaper rather than damage to the wall’s studs. It matters to investors because it has different treatment, monitoring and recurrence patterns than deeper cancers, driving demand for repeated outpatient procedures, local therapies and diagnostic tests that affect revenue, trial design and pricing dynamics in healthcare markets.
non-small cell lung cancermedical
A broad category of lung tumors that grow from the cells lining the airways and make up the majority of lung cancer cases; it includes several subtypes that behave and respond to treatment differently, like different models of the same car family. It matters to investors because its large patient population and variety of treatment options — surgery, traditional chemo, targeted drugs and immunotherapies — create major markets where clinical trial results, drug approvals or changing treatment guidelines can quickly affect a company’s revenue and stock value.
bacillus calmette-guérin (bcg)medical
Bacillus Calmette-Guérin (BCG) is a live, weakened strain of bacteria used as a vaccine against tuberculosis and as a longstanding immune-stimulating therapy for certain cancers, most commonly bladder cancer. Investors watch BCG because its supply, regulatory approvals, production capacity and clinical trial results can affect sales, treatment availability and healthcare costs—think of it like a widely used, older tool whose availability and regulatory standing can sway demand and company revenues.
immune checkpoint inhibitormedical
An immune checkpoint inhibitor is a type of medicine that helps the body's immune system recognize and attack cancer cells more effectively. It works by blocking certain signals that cancer uses to hide from immune defenses, allowing the immune system to target tumors. This breakthrough has led to new cancer treatments, making immune checkpoint inhibitors an important area of growth and innovation in the healthcare industry.
interleukin-15 (il-15) receptor agonistmedical
An interleukin-15 (IL-15) receptor agonist is a drug that mimics a natural immune signal to activate certain white blood cells, effectively turning up the immune system’s activity against disease. Investors care because these drugs are being developed as treatments that can boost the body’s ability to fight cancer and infections; success or failure in trials, safety profile and manufacturing can materially change a biotech company’s value, much like a thermostat controlling room temperature affects comfort and costs.
accelerated approvalregulatory
Accelerated approval is a process that allows new medical treatments to be approved more quickly than usual if they address serious or life-threatening conditions and show promising early results. For investors, it signals that a treatment may reach the market sooner, potentially boosting a company's prospects, but it also involves some uncertainty since full evidence of effectiveness is still being gathered.
cystectomymedical
Cystectomy is a surgical procedure that removes part or all of the urinary bladder, often done to treat severe disease such as cancer. For investors, it matters because the procedure drives demand for surgical tools, hospital services, reconstruction products (like urinary diversions), drugs and follow-up care, and it influences costs, reimbursement, clinical trial outcomes and adoption of new medical technologies—similar to replacing a major component in a machine and then buying parts and maintenance for the repair.
intravesicalmedical
Intravesical describes a medical treatment or procedure where a drug or therapy is placed directly into the bladder through a catheter rather than taken by mouth or injected into the bloodstream. For investors, it signals a focused delivery method that can increase local effectiveness and reduce whole‑body side effects, often affecting a product’s clinical value, patient convenience, regulatory path, and market niche — like watering a plant at its roots instead of spraying its leaves.
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ANKTIVA approved for patients with certain indications of non-muscle invasive bladder cancer and non-small cell lung cancer
Commercial availability achieved within two months of announcing MENA partnership with Biopharma and Cigalah Healthcare
First patients to be dosed have been identified and will soon receive initial ANKTIVA treatment
CULVER CITY, Calif.--(BUSINESS WIRE)--
ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced that ANKTIVA® (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:
In combination with Bacillus Calmette-Guérin (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
In 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)
ANKTIVA is being distributed through ImmunityBio’s partnerships with Biopharma and Cigalah Healthcare, leading healthcare distribution companies in the Middle East, with support from the company’s wholly owned subsidiary in Saudi Arabia.
“Thanks 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,” said Richard Adcock, President and CEO of ImmunityBio. “We 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.”
The 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
“We are pleased to support the introduction of this immunotherapy to physicians and their patients in Saudi Arabia,” said Tamer Eissa, General Manager, Biopharma. “We look forward to expanding access across the region.”
“This milestone represents an important step in expanding access to ANKTIVA for patients in Saudi Arabia,” said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. “We 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.”
ANKTIVA 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.
Saudi Arabia Indication and Usage
BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ:
ANKTIVA in combination with Bacillus Calmette-Guérin (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.
Non-small cell lung cancer (NSCLC):
ANKTIVA 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).
This 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.
U.S. IMPORTANT SAFETY INFORMATION
INDICATION AND USAGE: ANKTIVA® is an interleukin-15 (IL-15) receptor agonist indicated 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.
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 CIS do not have a complete response to treatment 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.
Please see the complete Indication and Important Safety Information and Prescribing Information for ANKTIVA® at Anktiva.com.
About ImmunityBio
ImmunityBio, Inc. is a biotechnology company focused on innovating, developing, and commercializing next-generation immunotherapies designed to activate the patient’s 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™ 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 and connect with us on X (Twitter), Facebook, LinkedIn, and Instagram.
About Cigalah Healthcare:
Based 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.
About Biopharma Middle East and Africa:
Biopharma-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.
References:
Saudi national lung cancer epidemiology from the Saudi Cancer Registry, 2015–2020 (AlOmar & AlAbdulKader, J Epidemiol Glob Health, 2025).
Based on 2018 GLOBOCAN cancer incidence data reported in Cancer incidence and mortality estimates in Arab countries (medRxiv, 2022).
Forward Looking Statements
This 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.
Such 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.
More 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.
ImmunityBio 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.
