ImmunityBio Receives EU Authorization for ANKTIVA Bladder Cancer Treatment

The European Commission granted conditional marketing authorization for ANKTIVA in combination with BCG for the treatment of adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. The authorization, issued in February 2026, marks the first immunotherapy approved in Europe for this indication, where no treatment was previously authorized for BCG-unresponsive disease.

The conditional marketing authorization enables commercial availability across all 27 European Union member states plus Iceland, Norway, and Liechtenstein, bringing the total number of countries where ANKTIVA is authorized to 33. The authorization follows the positive opinion adopted by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on December 11, 2025, which recommended authorization based on its determination that the benefit of making ANKTIVA available to patients—with a complete response rate of 71%—outweighed the risks.

ANKTIVA in combination with BCG for BCG-unresponsive NMIBC CIS is now authorized across four regulatory jurisdictions: the United States (FDA approval, April 2024), United Kingdom (MHRA approval, July 2025), Kingdom of Saudi Arabia (SFDA accelerated approval, January 2026), and the European Union (European Commission conditional marketing authorization, February 2026). The global regulatory footprint of 33 countries was built in under two years from initial FDA approval.

The conditional marketing authorization was based on results from the QUILT-3.032 study (NCT03022825), a single-arm, open-label, multicenter phase 2/3 clinical trial in 100 adults with BCG-unresponsive NMIBC CIS with or without papillary tumors who received ANKTIVA in combination with BCG administered intravesically. The trial demonstrated a complete response rate of 71% (95% CI: 61%, 80%), with responses ranging up to 54+ months and ongoing. The median duration of complete response was 26.6 months (95% CI: 13.0, 49.9 months).

Complete response rates among responders were 66% at 12 months and 42% at 24 months. Cystectomy-free survival among responders was 96% at 12 months, 90% at 24 months, and 84% at 36 months. Disease-specific survival for all patients was 99% at 24 months and 99% at 36 months.

Most treatment-related adverse events were grade 1 to 2. Grade 3 treatment-related adverse events occurred in 3% of patients; no grade 4 or 5 treatment-related adverse events were reported. As part of the conditional authorization, ImmunityBio will continue to follow up with trial participants and submit long-term safety and efficacy data to the EMA.

Bladder cancer represents a significant public health burden in the European Union, ranking as the fifth most common cancer overall and the seventh most frequently diagnosed cancer among men. The European Association of Urology and the World Bladder Cancer Patient Coalition estimate that more than 200,000 new cases of bladder cancer will be diagnosed in 2025. More than 150,000 patients are diagnosed annually with NMIBC across Europe. Approximately 75% of bladder cancer patients present with non-muscle invasive disease. The European Commission's decision addresses an unmet medical need where the primary alternative for BCG-unresponsive patients has been radical cystectomy.

The company reported preliminary 2025 net product revenue around $113 million and wrapped up the year sitting on roughly $242.8 million in cash and marketable securities. ImmunityBio disclosed that U.S. regulators want more information backing a possible resubmission of its supplemental biologics license application, or sBLA, for Anktiva—aimed at early-stage bladder cancer. The company plans to send in the materials the FDA requested within 30 days. No new clinical trials are part of this package.

ImmunityBio stock dropped 10.2% on February 13, 2026, finishing at $5.95 after swinging between $7.30 and $5.94 during the session. About 39.2 million shares traded hands. In after-hours moves, the stock recovered slightly, up 2.6% to $6.10. The company is scheduled to present at the ASCO Genitourinary Cancers Symposium, set for February 26-28, with its next earnings report expected on March 3.