On April 21, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, reported 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:
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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.
(Press release, ImmunityBio, APR 21, 2026, View Source [SID1234664613])