ImmunityBio Treats First European Bladder Cancer Patients
The company began administering its Anktiva and BCG combination in Germany and Austria after European conditional approval.
Updated on Nov. 4, 2026 in Cancer
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ImmunityBio has treated the first patients in Europe with Anktiva combined with BCG, in treatment sites in Germany and Austria. The therapy is for BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ.
Why it matters
The European Commission granted conditional approval in February 2026, covering all 27 EU countries plus Iceland, Norway and Liechtenstein. The first treatments mark the start of Anktiva's use in Europe for patients whose disease does not respond to standard BCG therapy.
The Phase 3 QUILT-2.005 trial enrolled 366 patients who had not previously received BCG therapy, and its topline results are expected this month. Efficacy and safety outcomes for the trial have not yet been reported.
The players
ImmunityBio
ImmunityBio is a biopharmaceutical company developing Anktiva, an immunotherapy for bladder cancer.
Accord Healthcare
Accord Healthcare is a generic and specialty pharmaceutical company that is providing commercial expertise and market access support for Anktiva in Europe.
Uniphar
Uniphar is an Irish healthcare company that is providing supply chain and distribution services for Anktiva across Europe.
The details
Anktiva is administered in combination with Bacillus Calmette-Guérin (BCG), a standard immune-based treatment for bladder cancer that some patients do not respond to. Accord Healthcare will provide commercial and market access support, while Uniphar will handle supply chain and distribution across Europe.
Timeline
February 2026: European Commission granted conditional approval for Anktiva.
Wednesday, November 4, 2026: First European patients treated with Anktiva plus BCG were announced.
November 2026: Topline results from the Phase 3 QUILT-2.005 trial are expected this month.
Fourth quarter 2026: ImmunityBio plans to file for FDA approval of expanded Anktiva use.
Big Picture
Conditional marketing authorization in the European Union allows a therapy to reach patients before full Phase 3 results are complete, and Anktiva's European launch follows this pathway. The approach places ImmunityBio's bladder cancer treatment ahead of its confirmatory trial data.
Patients with BCG-unresponsive bladder cancer in covered European countries may now have access to Anktiva plus BCG as a treatment option. Availability will depend on local regulatory and reimbursement decisions in each country.
The takeaway
Readers with BCG-unresponsive bladder cancer should discuss emerging options such as Anktiva with their oncologist to understand eligibility and availability in their region.
What happens next
ImmunityBio expects topline results from the Phase 3 QUILT-2.005 trial this month and plans to seek expanded FDA approval in the fourth quarter of 2026.
Further reading
Explore more on Cancer treatments and research developments.
Source note: This article includes information reported by Asianet News Network Pvt Ltd.
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