CULVER CITY, Calif. — ImmunityBio (NASDAQ: IBRX) said the European Medicines Agency has recommended granting conditional marketing authorization in the European Union for ANKTIVA (nogapendekin alfa inbakicept) in combination with Bacillus Calmette-Guérin (BCG) for the treatment of BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors.
The recommendation marks the first time an immunotherapy for this form of bladder cancer has received a positive marketing authorization recommendation in Europe. For patients whose disease does not respond to BCG, there are currently no authorized treatment options, with surgical removal of the bladder often remaining the primary alternative.
ImmunityBio said the recommendation reflects the EMA’s determination that the benefit of making ANKTIVA available to patients outweighs the risks associated with earlier access. The decision builds on existing approvals for the therapy in the United States and the United Kingdom.
“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.”
In an announcement accompanying the recommendation, the EMA said ANKTIVA offers a new treatment option for patients and addresses an important unmet medical need, noting that there are currently no authorized treatments for NMIBC that does not respond to BCG.
Bladder cancer remains a significant public health concern in the European Union, where it ranks among the most commonly diagnosed cancers. More than 150,000 people in Europe are diagnosed each year with non-muscle invasive bladder cancer, the most common form of the disease.
“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.”
The EMA’s recommendation was based on results from a single-arm clinical trial involving 100 adults with BCG-unresponsive NMIBC who received ANKTIVA in combination with BCG. In the study, 71 percent of patients achieved a complete response, with responses lasting an average of approximately 27 months and extending beyond 54 months in some cases. The complete response rate among responders was 66 percent at 12 months and 42 percent at 24 months. ImmunityBio said it will continue to follow trial participants and submit long-term safety and efficacy data to the EMA as part of post-marketing requirements.
Europe currently recognizes and has approved multiple BCG substrains, which ImmunityBio said supports broader access to standard-of-care therapy across the region. The company also said it is developing a recombinant BCG candidate to help address ongoing BCG shortages and support patient access.
The EMA’s opinion will now be forwarded to the European Commission for a final decision on EU-wide marketing authorization.
