MHRA issues positive opinion to avelumab for Early Access to Medicines Scheme

Merck and Pfizer have announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has issued an Early Access to Medicines Scheme (EAMS)-positive scientific opinion for avelumab. The drug is for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy. With this approval, the MHRA have confirmed a positive benefit-risk of avelumab in this patient population under EAMS.

The positive scientific opinion approval is based on results from a Phase III study, which demonstrated a significant improvement in median overall survival with avelumab as first-line maintenance plus best supportive care, compared with BSC alone.

Dr Mike England, Medical Director of Merck UK & Ireland said: “Bladder cancer is the 11^th most common cancer in the UK, with urothelial carcinoma being the most common type of bladder cancer, accounting for 90 percent of all cases. However, treatment options are limited and survival rates are poor. Therefore, we are delighted by the MHRA’s positive decision to provide earlt access to avelumab, as there is a significant unmet need in this therapy area for new treatment options for these patients. We believe this is a major advance in the existing standard of care and will improve patient outcomes.”

Dr Olivia Ashman, Oncology Medical Director, Pfizer UK said: “Avelumab is the first immunotherapy to demonstrate in a clinical trial a statistically significant improvement in overall survival as a first-line treatment for patients with advanced urothelial carcinoma. It is our greatest hope that our maintenance approach can eventually become part of routine clinical practice and significantly prolong survival for these patients.”

Avelumab is now available in the UK through the EAMS scheme for the first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy.

However, the companies note that aelumab is not licensed in the UK for locally advanced or metastatic urothelial carcinoma and a marketing authorisation application for this indication is currently under review by the European Medicines Agency (EMA).