EMA Highlights: New options for melanoma patients with poor prognosis

by Gary Finnegan: Keytruda (pembrolizumab) has been recommended by the European Medicines Agency (EMA) as monotherapy for the treatment of adult patients with advanced melanoma that cannot be surgically removed or where the cancer has spread to other parts of the body.
Melanoma is the most aggressive form of skin cancer and the leading cause of death from skin disease. The main risk factor for developing melanoma is ultraviolet (UV) light and intermittent exposure to the sun.
In 2012 more than 100,000 Europeans were diagnosed with melanoma and around 22,200 were estimated to have died from the disease.
If melanoma is detected early, it can often be removed by surgery and patients have a very good chance of survival. However, patients with advanced melanoma have a poor prognosis. It is estimated that five years after diagnosis of advanced melanoma only 10 to 30% of patients will still be alive.
For decades, standard chemotherapy was the only available treatment for patients with advanced melanoma. However, this therapy has limited benefits for patients and there are still important unmet medical needs for this condition, according to the EMA.
Keytruda’s active ingredient is pembrolizumab, a humanised monoclonal anti-programmed cell death-1 (PD-1) antibody. Pembrolizumab is a type of immunotherapy, which works by blocking a cellular pathway that limits the immune system from fighting melanoma cells. By blocking this pathway, pembrolizumab enables the body’s own immune system to fight the disease.
The Committee for Medicinal Products for Human Use (CHMP) based its recommendation for Keytruda on one uncontrolled study and on early results from two ongoing randomised controlled trials – one comparing Keytruda with standard chemotherapy and the other comparing Keytruda with ipilimumab, another melanoma treatment.
The Committee considered that the studies demonstrate the efficacy of Keytruda, both in patients who had not previously received ipilimumab and in patients who had previously received ipilimumab.
The Committee also looked at safety information from over 1,000 patients enrolled in clinical studies and considered that the safety profile of Keytruda appears manageable. A follow-up plan to monitor the safety and efficacy of Keytruda was agreed by the CHMP.