ImmunityBio, Inc. launches ANKTIVA in Saudi Arabia for bladder and lung cancer following Saudi Food and Drug Authority approval.
Written By: Pharmacally Medical News Desk
ImmunityBio, Inc. has announced the commercial launch of ANKTIVA in Saudi Arabia following authorization by the Saudi Food and Drug Authority, expanding access to immunotherapy in the Middle East and North Africa region.
The therapy is now available for adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ, with or without papillary disease, in combination with BCG, as well as for patients with metastatic non-small cell lung cancer (NSCLC) in combination with immune checkpoint inhibitors after progression on standard treatments.
The NSCLC indication has been granted under accelerated approval based on findings from a single-arm study linking increased absolute lymphocyte count with overall survival, with continued approval contingent on confirmatory trials.
ANKTIVA is being distributed through partnerships with Biopharma and Cigalah Healthcare, supported by the company’s local subsidiary.
Richard Adcock, President and CEO of ImmunityBio stated that the launch was achieved ahead of schedule through collaboration with regional partners and that efforts are ongoing to expand access across MENA.
Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio emphasized the company’s commitment to broadening availability of the therapy, supported by accumulating clinical data across indications, while regional partners noted their role in facilitating access for physicians and patients.
ANKTIVA was first approved by the U.S. Food and Drug Administration in April 2024 for BCG-unresponsive NMIBC CIS and has since received authorizations in multiple regions, including the United Kingdom, European Union, Macau, and Saudi Arabia.
The expansion comes amid a growing cancer burden in the region, where lung cancer is among the most common malignancies in Saudi Arabia and bladder cancer incidence remains elevated, underscoring the need for additional treatment options for patients who do not respond to existing standards of care.
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