On February 19, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, reported 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.
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"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.
IMPORTANT SAFETY INFORMATION
INDICATION AND USAGE: ANKTIVA in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours.
WARNINGS AND PRECAUTIONS: The possibility of severe systemic BCG-infections with the necessity of anti-tuberculosis therapy should be considered before initiating the BCG-therapy.
Delaying cystectomy in patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumours, treated with ANKTIVA therapy in combination with BCG could lead to development of muscle invasive or metastatic bladder cancer.
If patients with CIS that are medically eligible for cystectomy have not achieved a CR (absence of disease or low-grade Ta) to treatment after an induction course of ANKTIVA in combination with BCG at the 12-weeks assessment, cystectomy should be reconsidered as an alternative to re-induction. The risk of developing muscle-invasive or metastatic bladder cancer increases the longer cystectomy is delayed in the presence of persisting CIS.
DOSAGE AND ADMINISTRATION: For intravesical use only. ANKTIVA should NOT be administered by subcutaneous or intravenous or intramuscular use.
From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.
ANKTIVA is administered intravesically as a mixture with BCG.
USE IN SPECIFIC POPULATIONS: Pregnancy: Treatment is not recommended during pregnancy and in women of childbearing potential not using effective contraception.
Please see the Summary of Product Characteristics for ANKTIVA available on the European Medicines Agency website at www.ema.europa.eu.
(Press release, ImmunityBio, FEB 19, 2026, View Source [SID1234662784])