Merck & Co Submit Pembrolizumab to EU Regulators
Merck & Co yesterday announced that they have submitted pembrolizumab, to the European regulatory body, the European Medicines Agency.
The company confirmed that the European Medicines Agency (EMA) has accepted the marketing authorisation application for review of Merck & Co’s investigational anti-PD-1 antibody for the treatment of advanced melanoma.
The drug has demonstrated positive results in recent clinical trials, with one study showing that 69% of patients taking the drug were still alive after one year.
Head of clinical development at Merck Research Laboratories, Roy Baynes, commented that with the five-year survival rate currently at under 20%, “there remains a need to offer patients additional options.”
Pembrolizumab is also currently under priority review with the US Food and Drug Administration (FDA) for patients with advanced melanoma previously-treated with Bristol-Myers Squibb’s Yervoy.
In total, pembrolizumab is currently being assessed for over 30 different types of cancer, both as monotherapy and in combination, and by the end of 2014, the development programme for the drug will grow to in excess of 24 clinical trials, enrolling approximately 6,000 patients.