The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting a conditional marketing authorization in the EU for Anktiva to treat adults with non-muscle invasive bladder cancer (NMIBC) that is at high risk of growing and spreading. 

Anktiva (nogapendekin alfa inbakicept, ImmunityBio) is used in combination with Bacillus Calmette-Guérin (BCG) when the cancer does not respond to treatment with BCG alone.

Nogapendekin alfa inbakicept is an immunotherapy that binds to interleukin-15 receptor, activating an immune response that targets and destroys cancer cells. 

Anktiva is administered as a solution directly into the bladder — together with BCG — once a week for 6 weeks, and then as maintenance therapy.

EMA’s recommendation is based on the results of a single-arm clinical trial in 100 adults with BCG-unresponsive NMIBC who received Anktiva in combination with BCG over 6 weeks. Signs of cancer disappeared in 71% of patients, which lasted on average for about 27 months. 

Bladder cancer is the fifth most common cancer in Europe, affecting more than 200,000 people each year in the EU, with most cases being NMIBC. Moreover, bladder cancer has one of the highest lifetime costs of any cancer because of its high prevalence and costs of diagnostic tools and treatments. The annual financial burden imposed by bladder cancer in the EU is estimated at €4.9 billion. Projections show a significant rise by 2030, driven primarily by smoking and ageing populations. 

Current recommendations for treating patients with high-risk NMIBC consist of surgical removal of the cancer, followed by treatment with BCG. However, in many patients, the cancer does not respond or comes back. There are currently no authorized treatments for NMIBC when it does not respond to BCG, with the main treatment option being surgery to remove the bladder. As such, Anktiva addresses an unmet need.

The most common side effects with Anktiva are dysuria, hematuria, pollakiuria, urinary tract infection, micturition urgency, tiredness, chills, musculoskeletal pain, and fever. 

The CHMP’s opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorization.