ImmunityBio has taken decisive steps to accelerate ANKTIVA® (nogapendekin alfa inbakicept) access across Europe. Consequently, the company signed a commercial agreement and established an Irish unit to support the regional launch. Therefore, the expansion aims to improve treatment availability for eligible bladder cancer patients in more than 30 European countries.
In a move signaling significant growth, ImmunityBio partnered with Accord Healthcare. Specifically, they will commercialize ANKTIVA® (nogapendekin alfa inbakicept) in combination with Bacillus Calmette-Guérin (BCG). The therapy targets adults with BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ, with or without papillary tumors. As a result, this alliance will broaden market penetration across the European Union, the United Kingdom, Iceland, Liechtenstein, and Norway.
Under the partnership, Accord Healthcare will use an expanded sales, medical, and marketing team of over 100 professionals. In addition, they will support the rollout of ANKTIVA® (nogapendekin alfa inbakicept) across major European healthcare markets. Moreover, ImmunityBio will deploy an 85-person sales force dedicated to the commercialization effort.
To enhance regional operations, ImmunityBio opened a new Irish subsidiary based in Dublin. The unit will manage distribution infrastructure and, consequently, streamline commercial activities across Europe. This local presence further reinforces the company’s commitment to oncology markets that historically lack innovative treatment options.
“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. He emphasized that, therefore, Accord’s established market reach will help broaden patient access to ANKTIVA® (nogapendekin alfa inbakicept) throughout the region.
Paul Tredwell, Global CEO at Accord Healthcare, also noted that the collaboration reflects a shared commitment to bringing innovative cancer therapeutics to patients who currently face limited options.
The launch of ANKTIVA® (nogapendekin alfa inbakicept) follows recent approvals that expanded its global footprint. Moreover, conditional marketing authorization in the European Union complements approvals in the United States, the United Kingdom, and Saudi Arabia. Collectively, these approvals cover 33 countries, demonstrating growing recognition of the therapy’s clinical value.
ImmunityBio highlighted that ANKTIVA® (nogapendekin alfa inbakicept) is a first-in-class interleukin-15 (IL-15) receptor agonist. It activates and expands immune effector cells, including natural killer (NK) cells and T cells. Additionally, the therapy comes as a 400-microgram concentrate for intravesical suspension and helps restore antitumor immunity.
According to company data, patients treated with ANKTIVA® (nogapendekin alfa inbakicept) and BCG showed a complete response rate of approximately 71 percent. Consequently, these durable responses support its role in next-generation immunotherapy and offer options beyond radical cystectomy.
Recent advances in immunotherapy, such as checkpoint inhibitors, are transforming bladder cancer care. These therapies enhance the immune system’s ability to identify and eliminate cancer cells. Increasing use of immunotherapy, alongside innovative targeted treatments, is fueling demand for new bladder cancer therapies and reshaping the market by offering patients more personalized treatment options.
More than 150,000 individuals are diagnosed with non-muscle invasive bladder cancer each year in Europe and the United Kingdom. Of these, 10–20 percent present with carcinoma in situ, either with or without papillary disease, thus underscoring the unmet clinical need for effective therapies.
ImmunityBio is also pursuing additional regulatory efforts. Specifically, the company submitted responses to the U.S. FDA regarding expanded indications for patients with papillary-only disease. Moreover, it continues enrolling participants in randomized trials for BCG-naïve disease. These efforts aim to further validate and broaden the use of ANKTIVA® (nogapendekin alfa inbakicept) globally.
Industry analysts view this move as part of ImmunityBio’s larger strategy to build a sustainable global commercial infrastructure for its immunotherapy portfolio. With support from internal and external teams. The company is thus positioned to accelerate growth and transform the treatment landscape for bladder cancer patients in Europe.
As ImmunityBio and Accord roll out ANKTIVA® (nogapendekin alfa inbakicept) in the coming months, healthcare providers and patients will gain access to an innovative therapy. In addition, the collaboration represents a major milestone for the biotech industry and underscores the evolving role of immunotherapies in oncology care.
