Advanced renal cell carcinoma treatment receives Early Access to Medicines Scheme (EAMS) positive scientific opinion from the UK Medicines and Healthcare Products Regulatory Agency (MHRA).
Merck and Pfizer announced that the MHRA has issued an EAMS positive scientific opinion for avelumab used in combination with axitinib for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
The UK’s EAMS is a Government-led initiative that aims to provide patients with early access to innovative medicines in areas of significant unmet medical need. The positive scientific opinion, issued by the MHRA, for avelumab in combination with axitinib is based on information relating to the benefit and risks of the medicines and enables clinicians to prescribe the unlicensed treatment under their own responsibility.
Avelumab in combination with axitinib is not licensed in Europe for advanced RCC and is currently under review by European Medicines Agency.