ImmunityBio Gains Crucial European Market Access for Bladder Cancer Therapy

ImmunityBio has achieved a significant regulatory milestone in Europe, securing conditional marketing authorization from the European Commission for its therapy, ANKTIVA. This approval opens a substantial new market for the company and is expected to accelerate its commercial rollout. The key question now is how swiftly the biopharmaceutical firm can translate this authorization into tangible sales and distribution.

A New Treatment Option for a Specific Patient Group

The European Commission granted conditional approval for ANKTIVA (nogapendekin alfa inbakicept) this week. It is authorized for use in combination with Bacillus Calmette-Guérin (BCG) for adult patients diagnosed with BCG-unresponsive, non-muscle invasive bladder cancer (NMIBC) of the carcinoma in situ (CIS) type, with or without accompanying papillary tumors. According to the company, this combination therapy is the first of its kind approved in Europe for this specific patient population.

This conditional authorization is valid across all 27 member states of the European Union, as well as in Iceland, Liechtenstein, and Norway—covering a total of 33 countries. ImmunityBio highlighted that this achievement means ANKTIVA has gained a presence in four major regulatory territories in less than two years following its initial U.S. Food and Drug Administration (FDA) approval in April 2024.

Commercial Strategy and European Infrastructure

Shortly after the EU decision, ImmunityBio announced a strategic partnership with Accord Healthcare to handle the therapy’s commercialization across Europe. The agreement stipulates that Accord will deploy a team of over 100 professionals specializing in sales, medical affairs, and marketing to cover the United Kingdom, the EU, and nations within the European Free Trade Association.

Concurrently, the company revealed plans to establish an Irish subsidiary based in Dublin. This new entity will provide organizational support for the distribution and commercial activities of ANKTIVA throughout the European region.

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Clinical Data and Addressable Market Potential

The regulatory decision was based on clinical evidence from the QUILT-3.032 trial, an open-label, single-arm, multicenter Phase 2/3 study. ImmunityBio reported that the combination therapy demonstrated a complete response rate of 71% in patients with BCG-unresponsive NMIBC CIS.

The market opportunity in Europe is considerable. ImmunityBio cites data showing more than 150,000 annual NMIBC diagnoses across the continent. Furthermore, projections from the European Association of Urology and the World Bladder Cancer Patient Coalition estimate over 200,000 new bladder cancer cases in Europe for 2025, with approximately 75% classified as NMIBC. Prior to this new approval, the company notes that radical cystectomy was often the primary alternative for BCG-unresponsive patients.

Global Regulatory Progress and Pipeline Updates

ImmunityBio’s therapy has now received approvals in several key markets: the United States (April 2024), the United Kingdom (July 2025), Saudi Arabia (January 2026, via an accelerated process), and now the European Union (conditional). The company points out that Saudi Arabia remains the only market where ANKTIVA is approved for two indications, which includes metastatic non-small cell lung cancer.

On other regulatory fronts, ImmunityBio has submitted a response to an FDA data request concerning BCG-unresponsive, papillary-only NMIBC, and the review by the U.S. agency is currently underway. Additionally, patient recruitment is nearing completion for a randomized study focusing on BCG-naïve patients.