Culver City, California, United States; Germany and Austria, November 4, 2026
ImmunityBio, Inc. has announced that the first patients in Europe have 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 tumours. The initial treatments were administered in Germany and Austria, marking an important milestone in the European commercialization of the immunotherapy. The development follows the European Commission’s conditional marketing authorization granted in February 2026, allowing ANKTIVA to be used in eligible adult patients across the European Union and specified associated countries. ImmunityBio is working with Accord Healthcare and Uniphar to support commercialization, market access and distribution across European markets. The launch represents progress in expanding treatment options for patients whose bladder cancer has not responded adequately to previous BCG therapy.
ANKTIVA Reaches First Patients in Germany and Austria
The first European treatments with ANKTIVA plus BCG represent a significant step in bringing the immunotherapy into clinical practice following its European regulatory authorization. According to ImmunityBio, patients in Germany and Austria have begun receiving the combination treatment. Salzburg University Hospital, part of the Salzburg Regional Hospitals network, was identified as the first European center to administer the therapy. The treatment is intended for adults with BCG-unresponsive NMIBC with carcinoma in situ, with or without papillary tumours. Non-muscle-invasive bladder cancer is a form of the disease in which cancer has not invaded the bladder’s muscular wall. Although BCG is an established treatment for many patients with high-risk NMIBC, some patients experience persistent or recurrent disease despite treatment. For people with BCG-unresponsive disease, treatment decisions can be challenging. One established option is radical cystectomy, the surgical removal of the bladder, which can have substantial effects on quality of life and may not be appropriate for every patient. The availability of ANKTIVA in combination with BCG provides an additional treatment option for eligible patients seeking bladder-preserving approaches.
European Authorization Supports Wider Patient Access
The European Commission granted conditional marketing authorization for ANKTIVA in February 2026. The authorization covers all 27 European Union member states, as well as Iceland, Norway and Liechtenstein, for the specified adult patient population. Conditional marketing authorization is an important regulatory pathway that can allow earlier access to medicines addressing unmet medical needs while additional clinical evidence is collected. It is subject to specific obligations, including the submission of further data to confirm the medicine’s efficacy and safety. The authorization is also subject to annual renewal. To support the European rollout, ImmunityBio is collaborating with Accord Healthcare, which provides commercial expertise and market-access support. Dublin-based Uniphar is supporting the supply chain through services that include importation, storage, distribution, order-to-cash operations and commercial support. These partnerships are intended to help establish the infrastructure required to make ANKTIVA available across multiple markets. ImmunityBio retains global rights to ANKTIVA, while the partners contribute their regional commercial and distribution capabilities. The collaboration combines the company’s immunotherapy development expertise with established pharmaceutical market-access and specialist logistics networks.
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ANKTIVA Uses IL-15 Immunotherapy to Activate Immune Cells
ANKTIVA is a first-in-class interleukin-15 (IL-15) receptor agonist and an antibody-cytokine fusion protein designed to stimulate immune responses against cancer. Its mechanism involves activating and expanding important immune cells, including natural killer (NK) cells and CD8-positive killer T cells, which play roles in recognizing and eliminating cancer cells. When administered with BCG directly into the bladder, ANKTIVA is intended to strengthen local immune activity against bladder cancer. The combination approach aims to support a sustained antitumour immune response in patients whose disease has not responded to conventional BCG treatment alone. The European launch follows earlier clinical development and regulatory progress for the product. However, conditional authorization means additional evidence is still required to confirm its long-term benefit and safety. Treatment decisions must also account for the possibility of disease progression, and delaying appropriate surgical intervention in patients who do not respond can carry significant risks. Overall, the first European treatments with ANKTIVA mark an important commercialization milestone for ImmunityBio and expand access to an immunotherapy option for eligible patients with difficult-to-treat bladder cancer. The rollout in Germany and Austria provides an initial step toward broader availability, supported by Accord Healthcare and Uniphar. Continued clinical follow-up, regulatory commitments and effective distribution will be important as the therapy becomes available across additional European markets.
Source: ImmunityBio press release
