New melanoma drug approved by European Commission

The European Commission has granted a marketing authorisation for pembrolizumab (Keytruda) as monotherapy for the treatment of advanced (unresectable or metastatic) melanoma in adults, which signals the end of the Early Access to Medicines Scheme (EAMS) for the first medicine made available through the scheme. Approximately 450 patients were enrolled on EAMS for this medicine in the UK. 

For patients already on EAMS, MSD has committed to continue to supply pembrolizumab free of charge for up to two years from initiation of treatment or until NICE issues a positive final recommendation or an interim NHS England commissioning decision is published. To ensure pembrolizumab is made available to new advanced melanoma patients in the UK as rapidly as possible, MSD UK is now working closely and collaboratively with Government, NHS, NICE, SMC and other stakeholders.

Pembrolizumab is one of the first of a new class of immunotherapies that work making the cancer cell ‘visible’ to the immune system so it can be attacked by the body’s natural defence mechanisms. 

Dr James Larkin is a Consultant Medical Oncologist at The Royal Marsden and was Principal Investigator for one of the studies the license was based on. He said: “Although the incidence of malignant melanoma is increasing, most cases are diagnosed at an early stage. However, the management of patients with advanced disease is much more challenging. Immuno-oncology drugs – such as pembrolizumab – are designed to unleash the body’s own immune system against cancer and are significantly prolonging the lives of some people with hard-to-treat forms of melanoma. So today’s news is a major step forward for patients with advanced melanoma.”

Gillian Nuttall from Melanoma UK added: “Patients with advanced melanoma are in a very difficult position. The addition of pembrolizumab to existing treatments is another very encouraging step for the melanoma community. Living with advanced disease presents many problems and today’s news will bring hope to many.”

The European Commission license of pembrolizumab is based on data from three clinical studies conducted in more than 1,500 first-line and previously-treated patients with advanced melanoma.

The safety supporting the European license of pembrolizumab was based on 1,012 advanced melanoma patients. The majority of adverse reactions reported were of Grade 1 or 2 severity. The most serious adverse reactions were immune or infusion related.