UK Medicines and Healthcare Products Regulatory Agency (MHRA) issues an Early Access to Medicines Scheme (EAMS) positive scientific opinion for Avelumab as First-Line Maintenance Treatment for patients with Locally Advanced or Metastatic Urothelial Carcinoma
Feltham (Merck) & Walton Oaks (Pfizer) – Merck and Pfizer announce that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has issued an Early Access to Medicines Scheme (EAMS) positive scientific opinion for avelumab for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy.1 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 the Phase III JAVELIN Bladder 100 study, which demonstrated a significant 7.1-month improvement in median overall survival (OS) with avelumab as first-line 
maintenance plus best supportive care (BSC) compared with BSC alone: 21.4 months (95% CI: 18.9 to 26.1) vs. 14.3 months (95% CI: 12.9 to 17.9).1,2 This statistically significant improvement in OS represents a 31% reduction in the risk of death in the overall population (HR 0.69; 95% CI: 0.56 to 0.86; 2-sided P=0.001).2 OS was measured from the time of randomisation, after patients were treated with four to six cycles of gemcitabine plus cisplatin or carboplatin over a period of approximately four months.2 The JAVELIN Bladder 100 interim analysis results were presented at the ASCO 2020 Virtual Scientific Meeting.3
Platinum-based chemotherapy is currently the first-line standard of care for eligible patients with advanced disease based on high initial response rates. However, most patients will ultimately experience disease progression within nine months of initiation of treatment4,5 and only 5% of patients with metastatic disease will live longer than five years.6
Dr Mike England, Medical Director, Merck UK & Ireland said: “Bladder cancer is the eleventh 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 early 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.1
Avelumab 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).
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