On November 4, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, reported that the first patients in Europe received treatment with ANKTIVA (nogapendekin alfa inbakicept) in combination with Bacillus Calmette-Guérin (BCG) for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. The treatments were administered in Germany and Austria, marking an important step in expanding patient access to ANKTIVA across Europe.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The treatment milestone follows the European Commission’s conditional marketing authorization of ANKTIVA in February 2026 for the treatment of adult patients with BCG-unresponsive NMIBC with carcinoma in situ (CIS), with or without papillary tumors. The conditional marketing authorization includes all 27 European Union (EU) member states plus Iceland, Norway and Liechtenstein.

"Our patients should benefit from medical innovations at the earliest possible stage and receive treatment tailored to their specific disease. Through our Bladder Cancer Program, we bring together specialized clinical care and scientific expertise to achieve this goal," Priv. Doz. Dr. Maximilian Pallauf, FEBU, Director of the Bladder Cancer Program, and Univ. Prof. Dr. Lukas Lusuardi, FEBU, Head of the Department of Urology and Andrology at Salzburg University Hospital of the Salzburg Regional Hospitals (SALK). "Being the first center in Europe to administer ANKTIVA for the treatment of BCG-unresponsive non-muscle-invasive bladder cancer highlights our pioneering role in translating novel therapeutic approaches into routine clinical practice."

Accord Healthcare, a leading European pharmaceutical company and major player in oncology and urology, is providing commercial expertise and market access support, while Dublin-based Uniphar is providing supply chain and distribution services to facilitate ANKTIVA availability across European markets.

"Treating the first patients in Europe represents an important step in expanding access to ANKTIVA across the region," said Richard Adcock, President and Chief Executive Officer of ImmunityBio. "Our collaborations with Accord and Uniphar bring together commercial expertise, local market knowledge, and distribution capabilities to help make ANKTIVA available to more eligible patients."

"We are delighted to see the first patients in Europe receive ANKTIVA, marking an important step for those seeking additional treatment options," said Paul Tredwell, Global Chief Executive Officer of Accord Healthcare. "Our partnership with ImmunityBio combines scientific innovation with the commercial infrastructure and local expertise needed to expand patient access across Europe."

"This partnership reinforces Uniphar’s role as a trusted international partner for biotechnology companies bringing highly specialized therapies to patients across complex markets," said Brian O’Shaughnessy, Chief Commercial Officer at Uniphar. "By combining our regulatory, quality, supply chain, distribution, order-to-cash capabilities, we can support ImmunityBio with a scalable platform that enables launch readiness and ongoing commercial supply for ANKTIVA."

Unmet Medical Need in Europe

Bladder cancer represents a significant public health burden in the European Union, ranking as the fifth most common cancer overall and the seventh most frequently diagnosed cancer among men.1,2 The European Association of Urology and the World Bladder Cancer Patient Coalition estimate that more than 200,000 new cases of bladder cancer were diagnosed in 2025.3 Approximately 75% of these cases are NMIBC, the most common form of the disease, which is confined to the bladder lining and has not invaded the underlying muscle layer. For patients whose NMIBC does not respond to BCG therapy, there were no authorized treatment options in the European Union prior to this authorization. The primary alternative has been radical cystectomy, which carries significant morbidity, affects quality of life, and is not suitable for all patients.

(Press release, ImmunityBio, NOV 4, 2026, View Source [SID1234674170])