ImmunityBio (NASDAQ: IBRX) has received conditional marketing authorization from the European Commission 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, with a 71% complete response rate, is the first immunotherapy to receive marketing authorization in Europe for this indication.
This authorization expands the global access of Anktiva to 33 countries. In addition to the European Union (EU) member states, the authorization includes Iceland, Norway, and Liechtenstein. Anktiva is now authorized across four regulatory jurisdictions, including the United States (FDA, April 2024), United Kingdom (MHRA, July 2025), and the Kingdom of Saudi Arabia (SFDA, January 2026).
Anktiva's conditional marketing authorization was based on data from the QUILT-3.032 study, a single-arm, open-label, multicenter phase 2/3 clinical trial. Key efficacy findings from the trial include a 71% complete response rate, a median duration of complete response of 26.6 months, and cystectomy-free survival among responders at 12 months of 96%, at 24 months of 90%, and at 36 months of 84%. The most common adverse reactions reported were grade 1 to 2, with no grade 4 or 5 treatment-related adverse events.
The European Commission's decision addresses an unmet medical need where the primary alternative for BCG-unresponsive patients has been radical cystectomy. 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. Approximately 75% of these cases are NMIBC, which is the most common form of the disease.
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. It 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.
The conditional marketing authorization is subject to annual renewal, and ImmunityBio is required to submit long-term follow-up results from ongoing studies to confirm the efficacy and safety of Anktiva. Anktiva in combination with BCG is indicated for the treatment of adult patients with BCG-unresponsive NMIBC with CIS with or without papillary tumors.
With Anktiva now authorized in 33 countries, ImmunityBio is focused on ensuring timely pricing, reimbursement, and patient access across Europe. Six BCG strains are available in Europe for use in combination with Anktiva, and the company is expeditiously developing a recombinant BCG candidate to address ongoing BCG shortages in the U.S. Today the company's shares have moved 39.75% to a price of $5.52. If you want to know more, read the company's complete 8-K report here.
