ImmunityBio’s ANKTIVA Plus BCG Becomes First Authorised Treatment In Europe For BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

ImmunityBio has received conditional marketing authorisation from the European Commission for its immunotherapy ANKTIVA® (nogapendekin alfa inbakicept), to be used in combination with Bacillus Calmette-Guérin (BCG) for adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS), with or without papillary tumours. This marks the first authorised treatment in Europe specifically for this patient population and represents a major step forward in addressing a long-standing treatment gap.

The approval follows a positive recommendation issued in December 2025 by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). The decision was supported by data from the QUILT-3.032 study, which showed a 71% complete response rate and a median duration of response of 26.6 months, with some patients maintaining responses beyond 54 months. Regulators determined that the therapy’s clinical benefits outweighed the risks associated with earlier access under a single-arm trial design. As part of the conditional approval, ImmunityBio will continue to provide long-term safety and efficacy data.

“The European Commission’s authorisation 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 authorised 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 authorised in 33 countries from the United States and the 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.”

With this authorisation, ANKTIVA plus BCG is now approved in 33 countries across four regulatory jurisdictions, including prior approvals from the U.S. Food and Drug Administration in April 2024, the Medicines and Healthcare products Regulatory Agency in July 2025, and the Saudi Food and Drug Authority in January 2026. The European authorisation covers all 27 EU member states as well as Iceland, Liechtenstein, and Norway. Notably, Saudi Arabia remains the only region where ANKTIVA is approved for two indications: metastatic non-small cell lung cancer and subcutaneous administration.

“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.”

Bladder cancer is the fifth most common cancer in the EU and predominantly presents as NMIBC, which accounts for approximately 75% of cases. Until now, patients in Europe whose disease failed to respond to BCG had no approved treatment alternatives other than radical cystectomy, a major surgical procedure with a significant impact on quality of life. Clinical data supporting the approval showed strong cystectomy-free survival rates and manageable safety outcomes, with most adverse events classified as mild to moderate and only 3% of patients experiencing grade 3 treatment-related events.