ImmunityBio, a leading immunotherapy company, has announced that the European Medicines Agency (EMA) has recommended granting conditional marketing authorization for its therapy in patients with hard-to-treat bladder cancer.

The move could provide earlier access to a therapy for patients whose only alternative is bladder removal surgery.

The nod involved the use of ANKTIVA (nogapendekin alfa inbakicept) in combination with Bacillus Calmette-Guérin (BCG) for patients suffering from BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma.

“ANKTIVA represents an important evolution in the treatment of NMIBC CIS, strengthening the immune response and improving the durability of BCG,” said Dr Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio.

“Hundreds of patients in the U.S. are already experiencing the benefits of this therapy, and our goal is to make it available to patients in Europe and other parts of the world as quickly and responsibly as possible, to ensure avoidance of a radical cystectomy. We are pleased that the EMA issued this positive recommendation based on our single-arm trial and through a regulatory process that allows earlier access to ANKTIVA, when as stated in the EMA announcement, the benefit of a medicine’s immediate availability to patients outweighs the inherent risks.”

The EMA emphasized the therapy’s significance: “ANKTIVA offers a new treatment option for patients and addresses an important unmet need. There are currently no authorised treatments for NMIBC that does not respond to BCG.”

Bladder cancer is a major public health issue in Europe, ranking as the fifth-most common cancer overall and seventh among men. More than 200,000 new cases are expected in 2025, with roughly 75% classified as NMIBC, which affects only the bladder lining and not the muscle layer.

“We are looking forward to finalizing plans to bring our innovative treatment to qualified EU patients,” said Richard Adcock, President and CEO of ImmunityBio. “With the United States’ new Most-Favored-Nation Prescription Drug Pricing policy now in effect, we are thoughtfully assessing our approach to launching in Europe to ensure broad, equitable, and sustainable access.”

“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,” added Adcock.

Conditional marketing authorization in the EU is designed to accelerate access for therapies addressing unmet medical needs, allowing approval when immediate availability outweighs potential risks. The EMA’s recommendation now goes to the European Commission for final EU-wide approval.