It has just been announced that the avelumab plus axitinib combination has received positive scientific opinion for the Early Access to Medicines Scheme (EAMS) for the first-line treatment of advanced renal cell carcinoma (RCC).
EAMS aims to give patients with life-threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need.
Under the scheme, the Medicines and Healthcare products Regulatory Agency (MHRA) will give a scientific opinion on the benefit/risk balance of the medicine, based on the data available when the EAMS submission was made.
The opinion lasts for a year and can be renewed.
The scheme is voluntary and the opinion from MHRA does not replace the normal licensing procedures for medicines.
Kidney cancer patients in the UK will have earlier access to this promising new drug combination before the license is approved. The scientific opinion of the MHRA provides additional information on the benefits and risks of the avelumab plus axitinib combination to help patients and clinicians make a decision whether to use the combination before the license is approved.
For more information, please visit the EAMS website on GOV.UK