www.ema.europa.eu
EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Anktiva (nogapendekin alfa inbakicept) to treat adults with a type of bladder cancer that affects the lining of the bladder (non-muscle invasive bladder cancer, NMIBC) and that is at high risk of growing and spreading (carcinoma in situ, with or without papillary tumours). Anktiva is used when the cancer does not respond to treatment with Bacillus Calmette-Guérin (BCG), a therapy that stimulates the immune system to help treat bladder cancer.
Anktiva is given as a solution directly into the bladder, together with BCG, once a week for 6 weeks, and then as maintenance therapy.
Bladder cancer is one of the most common cancers in the EU, affecting over 200,000 people each year, with most cases being NMIBC. 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…