3 September 2020 - Merck and Pfizer’s Bavencio (avelumab) is now available under the UK's Early Access to Medicines Scheme giving some patients with bladder cancer the chance to receive treatment with the immunotherapy before its approval in Europe.
The positive scientific opinion issued by the UK Medicines and Healthcare Products Regulatory Agency allows patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy to get first-line maintenance treatment with the drug.
The decision rides on data from the Phase III JAVELIN Bladder 100 study, which showed a significant 7.1-month improvement in median overall survival with Bavencio as first-line maintenance plus best supportive care compared with best supportive care alone: 21.4 months versus 14.3 months.