• ANKTIVA plus BCG, with a 71% complete response rate, is the first immunotherapy to receive marketing authorization in Europe for non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors, where no treatment was previously authorized for BCG-unresponsive disease
• European Commission conditional marketing authorization enables commercial availability across all 27 European Union (EU) member states plus Iceland, Norway, and Liechtenstein, bringing the total number of countries where ANKTIVA is authorized to 33
• ANKTIVA is now authorized across four regulatory jurisdictions: the United States (FDA, April 2024), United Kingdom (MHRA, July 2025), Kingdom of Saudi Arabia (SFDA, January 2026), and the European Union (EC, February 2026)
• More than 150,000 patients are diagnosed annually with NMIBC across Europe; the European Commission’s decision addresses an unmet medical need where the primary alternative for BCG-unresponsive patients has been radical cystectomy
• Global regulatory footprint of 33 countries built in under two years from initial FDA approval

ImmunityBio (NASDAQ: IBRX), a commercial-stage immunotherapy company,  announced that the European Commission has granted conditional marketing authorization 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 in combination with BCG is the first authorized treatment in Europe for BCG-unresponsive NMIBC CIS. With this authorization, ANKTIVA is now approved in 33 countries spanning four regulatory jurisdictions, establishing a global commercial footprint in under two years from initial U.S. Food and Drug Administration (FDA) approval.

The conditional marketing 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%, a median duration of complete response of 26.6 months, and individual responses ranging up to 54+ months and ongoing outweighs the risks associated with earlier access from a single-arm trial. The authorization covers all 27 EU member states Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden as well as Iceland, Liechtenstein, and Norway. ANKTIVA plus BCG is the first immunotherapy to receive marketing authorization in Europe for this NMIBC indication.

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.

“The European Commission’s authorization of ANKTIVA in combination with BCG marks a defining moment for patients with BCG-unresponsive NMIBC CIS across Europe, who until now have had no authorized treatment and faced radical cystectomy as their only alternative,” said Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio. “With ANKTIVA now authorized in 33 countries from the United States and United Kingdom to the European Union and Saudi Arabia, we have built the broadest global access platform for an immunotherapy in this indication. With more than 80% of treated patients preserving their bladder through three years of follow-up, ANKTIVA represents a meaningful advance designed to strengthen the immune response and extend the durability of BCG.”

Global Regulatory Footprint

ANKTIVA in combination with BCG for BCG-unresponsive NMIBC CIS is now authorized across four regulatory jurisdictions encompassing 33 countries:

• United States: FDA approval, April 2024 (NMIBC CIS with or without papillary tumors)
• United Kingdom: MHRA approval, July 2025 (NMIBC CIS with or without papillary tumors)
• Kingdom of Saudi Arabia: SFDA accelerated approval, January 2026 (NMIBC CIS with or without papillary tumors; metastatic non-small cell lung cancer)
• European Union (30 countries): European Commission conditional marketing authorization, February 2026 (NMIBC CIS with or without papillary tumors). Covers all 27 EU member states plus Iceland, Liechtenstein, and Norway.

The Kingdom of Saudi Arabia remains the only jurisdiction where ANKTIVA has received authorization in two indications, including the first approval globally for ANKTIVA in metastatic non-small cell lung cancer and the first approval for subcutaneous administration.

Unmet Medical Need in Europe

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.^1,2 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 2025.³ Approximately 75% of these cases are NMIBC, the most common form of the disease, which is confined to the bladder lining and has not invaded the underlying muscle layer. For patients whose NMIBC does not respond to BCG therapy, there were no authorized treatment options in the European Union prior to this authorization. The primary alternative has been radical cystectomy, which carries significant morbidity, affects quality of life, and is not suitable for all patients.

Notably, unlike the United States, where only one BCG strain is approved, Europe recognizes and has approved approximately six major BCG strains, making standard-of-care BCG therapy broadly available across the region and supporting a reliable supply for the ANKTIVA plus BCG combination regimen.⁴

“Reaching 33 countries in under two years from our first regulatory approval is a testament to the strength of the clinical evidence and the urgency of the unmet need in BCG-unresponsive bladder cancer,” said Richard Adcock, President and CEO of ImmunityBio. “We are now focused on working with EU member states to ensure timely pricing, reimbursement, and patient access across Europe. Six BCG strains are available in Europe for use in combination with ANKTIVA, and we are expeditiously developing our recombinant BCG candidate to address ongoing BCG shortages in the U.S. and help ensure that all eligible patients can benefit from this treatment.”

Clinical Evidence Supporting Authorization

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.^{5, 6}

Key Efficacy Findings:

• Complete response (CR) rate: 71% (95% CI: 61%, 80%), with responses ranging up to 54+ months and ongoing
• Median duration of complete response: 26.6 months (95% CI: 13.0, 49.9 months)
• Complete response rate among responders at 12 months: 66%; at 24 months: 42%
• Cystectomy-free survival among responders: 96% at 12 months, 90% at 24 months, and 84% at 36 months
• Disease-specific survival for all patients: 99% at 24 months and 99% at 36 months

Key Safety Findings (Cohorts A and B combined, n=180):

• 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
• Most common adverse reactions: dysuria,