Eight months after receiving approval from the U.S. Food and Drug Administration (FDA), a new treatment for metastatic bladder cancer has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
This positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medications for all EU member states, as well as Iceland, Liechtenstein and Norway. The treatment is expected to be approved across the European Union, with the additional bureaucratic process likely to take about one to two months. 2 View gallery Metastatic bladder cancer ( Photo: Shutterstock ) The treatment combines the drugs Enfortumab Vedotin (Padcev) and Keytruda (pembrolizumab) for first-line treatment of advanced bladder cancer.
It is the first and only therapy that offers an effective alternative to chemotherapy, which has been the standard treatment for patients with metastatic or inoperable bladder cancer. The positive opinion is based on a clinical trial that showed patients receiving this drug combination doubled their survival time compared to those treated with chemotherapy. In March, the European Society for Medical Oncology (ESMO) and the American Cancer Society (NCCN) updated their guidelines, recommending this combination as the first-line treatment for patients with metastatic bladder cancer.
Dr. Michal Sarfaty, an expert in clinical oncology and head of the Uro-oncology Unit at Sheb.