ImmunityBio Expands Access to ANKTIVA® in EU with New Distribution Partnership and Opens Irish Subsidiary to Support European Launch
ImmunityBio, Inc. a commercial-stage immunotherapy company, today announced a partnership with Accord Healthcare to provide access to ANKTIVA® (nogapendekin alfa inbakicept) in combination with Bacillus Calmette-Guérin (BCG) for eligible patients in the European Union with BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ (NMIBC CIS), with or without papillary disease. ImmunityBio also announced the establishment of an Irish subsidiary in Dublin to support the company’s distribution and commercialization strategy throughout Europe.
Our partnership with Accord marks a significant step in our European growth strategy and our mission to redefine cancer care,” said Richard Adcock, President and CEO of ImmunityBio. “Accord’s scale, oncology leadership, and commercial reach support our goals to broaden patient access to ANKTIVA and unlock its full commercial potential in Europe.
As part of the partnership, Accord Healthcare will utilize over 100 Sales, Medical, and Marketing professionals to drive commercialization of ANKTIVA in the UK, European Union, as well as European Free Trade Association members Iceland, Liechtenstein, and Norway.
Our partnership with ImmunityBio reflects our shared commitment to expanding access to innovative cancer therapies for patients in Europe,” said Paul Tredwell, Global CEO at Accord Healthcare. “ANKTIVA represents an important advancement for eligible patients with BCG-unresponsive NMIBC CIS, and we are pleased to support its introduction across our markets.
With approvals now spanning 33 countries, ImmunityBio has expanded global access to ANKTIVA for those with BCG-unresponsive NMIBC CIS, with or without papillary disease,” said Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio. “The 71% complete response rate and the durability of those responses support ANKTIVA’s role as a foundational backbone of next-generation immunotherapy for bladder cancer. Our goal is to further broaden access by rapidly completing the randomized trial in patients with BCG-naïve disease. In parallel, we have submitted our response to the U.S. FDA’s request for additional data related to BCG-unresponsive papillary-only NMIBC, and we await the Agency’s review.
ANKTIVA in combination with BCG for the treatment of BCG-unresponsive NMIBC CIS is now authorized across four major regulatory jurisdictions, encompassing 33 countries. These approvals include the United States (FDA, April 2024), the United Kingdom (MHRA, July 2025), the Kingdom of Saudi Arabia (SFDA accelerated approval, January 2026), and the European Union, where the European Commission granted conditional marketing authorization in February 2026 covering 27 EU member states plus Iceland, Liechtenstein, and Norway.
About ANKTIVA® (nogapendekin alfa inbakicept)
ANKTIVA is a first-in-class interleukin-15 (IL-15) receptor agonist (ATC code: L03AC03) consisting of an IL-15 mutant (IL-15N72D) bound to an IL-15 receptor alpha Fc fusion protein. In the European Union, ANKTIVA is available as a 400 µg concentrate for intravesical suspension.
ANKTIVA binds with high affinity to IL-15 receptors on natural killer (NK) cells, CD4+ T cells, and CD8+ T cells, activating and expanding these immune effector populations. By activating NK cells, ANKTIVA addresses tumor immune escape mechanisms, while simultaneously restoring memory T cell activity to generate durable antitumor responses. ANKTIVA has improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced antitumor activity compared to native IL-15 in vivo.
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