ImmunityBio Secures EU Authorization for ANKTIVA, Expands to 33 Countries

The European Commission has granted conditional marketing authorization for ANKTIVA (nogapendekin alfa inbakicept) 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 tumors. ANKTIVA in combination with BCG is the first authorized treatment in Europe for BCG-unresponsive NMIBC CIS.

The authorization covers all 27 EU member states—Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden—as well as Iceland, Liechtenstein, and Norway. With this authorization, ANKTIVA is now approved in 33 countries spanning four regulatory jurisdictions, establishing a global commercial footprint in under two years from initial U.S. Food and Drug Administration (FDA) approval.

The conditional marketing authorization follows the positive opinion adopted by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on December 11, 2025, which recommended authorization based on its determination that the benefit of making ANKTIVA available to patients—with a complete response rate of 71%, a median duration of complete response of 26.6 months, and individual responses ranging up to 54+ months and ongoing—outweighs the risks associated with earlier access from a single-arm trial. More than 80% of treated patients preserved their bladder through three years of follow-up.

ImmunityBio announced a partnership with Accord Healthcare to provide access to ANKTIVA in the European Union for eligible patients with BCG-unresponsive NMIBC CIS, with or without papillary disease. 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. ImmunityBio also announced the establishment of an Irish subsidiary in Dublin to support the company's distribution and commercialization strategy throughout Europe.

ANKTIVA in combination with BCG for the treatment of BCG-unresponsive NMIBC CIS is now authorized across four major regulatory jurisdictions. 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.

Approximately 157,000 people are diagnosed annually with non-muscle invasive bladder cancer (NMIBC) in the EU and UK, with an estimated 10% to 20% presenting with NMIBC carcinoma in situ, with or without papillary tumors. The European Commission's decision addresses an unmet medical need where the primary alternative for BCG-unresponsive patients has been radical cystectomy.

ImmunityBio has submitted a response to the U.S. FDA's request for additional data related to BCG-unresponsive papillary-only NMIBC, and awaits the Agency's review. The company's randomized BCG naïve trial is nearing full enrollment.

As part of the conditional authorization, ImmunityBio will continue to follow up with trial participants and submit long-term safety and efficacy data to the EMA. ANKTIVA is a first-in-class interleukin-15 (IL-15) receptor agonist consisting of an IL-15 mutant (IL-15N72D) bound to an IL-15 receptor alpha Fc fusion protein. 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.