European Commission approves Merck’s Keytruda for melanoma drug
pharmafile | July 23, 2015 | News story | Sales and Marketing |
The European Commission has approved Merck’s Keytruda (pembrolizumab) as a skin cancer treatment.
Keytruda, the company’s successful anti-PD-L1 therapy and competitor to Bristol-Myers Squibb’s Opdivo (nivolumab), is used for the treatment of advanced (unresectable or metastatic) melanoma in adults. It is now approved in Europe for this group of patients, as a first-line treatment and for people with skin cancer who have previously tried other treatments.
The European Commission’s approval of Keytruda is based on data from three clinical studies conducted in more than 1,500 first-line and previously-treated patients with advanced melanoma. In a Phase III data, Keytruda outperformed another anti-PD-L1 therapy, to provide a statistically superior survival benefit as a monotherapy compared to BMS’ Yervoy (ipilimumab), the current standard of care for advanced melanoma.
“Merck has long-believed that innovation and access must go hand-in-hand, which is why we work to bring forward new innovations, and ensure access to those innovations,” says Deepak Khanna, senior vice president and regional president, Europe, MSD Oncology. “Merck is committed to working collaboratively with governments and other stakeholders to ensure that Keytruda will be made available to advanced melanoma patients in Europe as rapidly as possible.”
The EC decision means Merck can begin marketing Keytruda in all 28 EU member states at the approved dose of 2 mg/kg every three weeks.
“The European approval supports our goal of accelerating immuno-oncology research for the benefit of patients around the world,” says Dr Roger Perlmutter, president of Merck Research Laboratories. “We believe that the broad data set supporting this approval helps illustrate the significant potential of Keytruda to treat advanced melanoma, a devastating disease.”
Now that is has European-sign off, Keytruda is now approved in more than 35 countries for the treatment of advanced melanoma. Merck is pushing ahead with the pursuit of further approvals by advancing a clinical development program for Keytruda consisting of more than 100 clinical trials of more than 30 tumour types in more than 16,000 patients – both as a monotherapy and in combination with other therapies.
Yasmita Kumar
