The European Commission has granted conditional marketing approval to Anktiva in combination with BCG for adults with high-grade, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Until now, patients in Europe whose cancer did not respond to BCG often had very limited options and frequently needed radical cystectomy, the surgical removal of the bladder.
The decision is based on results from the QUILT-3.032 trial involving 100 patients. The treatment achieved a 71% complete response rate, meaning most patients had no detectable cancer. Among those who responded, 66% remained cancer-free at 12 months and 42% at 24 months. At three years, 84% of responders had avoided bladder removal, and the disease-specific survival rate at 36 months was 99%.
The therapy was well tolerated. Most side effects were mild, such as painful urination, fatigue, and chills. Only 3% of patients experienced more serious side effects, and no life-threatening or fatal events were reported. With this authorization, Anktiva is now approved in 33 countries, including the United States and the United Kingdom. It is given directly into the bladder once a week for six weeks, followed by maintenance treatment for up to three years in eligible patients.