Merck & Co has filed its much-touted checkpoint inhibitor pembrolizumab with regulators in Europe.
The US giant noted that the European Medicines Agency has accepted for review its marketing authorisation application for the investigational anti-PD-1 antibody for the treatment of advanced melanoma. The drug caused a stir at the American Society of Clinical Oncology meeting last month with one study showing that 69% of the advanced melanoma patients taking pembrolizumab were alive after one year.
Roy Baynes, head of clinical development, Merck Research Laboratories, said that with the five-year survival rate for patients with advanced melanoma at less than 20%, “there remains a need to offer patients additional options”. A Biologics License Application for pembrolizumab is under priority review with the US Food and Drug Administration for patients with advanced melanoma previously-treated with Bristol-Myers Squibb's Yervoy (ipilimumab).
The Prescription Drug User Fee Act date for pembrolizumab, which also has breakthrough therapy designation, is October 28. If all goes well, it could be the first anti-PD-1 drug approved on both sides of the Atlantic.
Pembrolizumab is being evaluated across more than 30 types of cancers, as monotherapy and in combination, and by the end of 2014, the development programme will grow to more than 24 clinical trials, enrolling some 6,000 patients.
Chemo nausea drug for children
Merck’s good day continued with the news that a late-stage trial trial has shown the safety and efficacy of Emend (aprepitant) in the prevention of chemotherapy-induced nausea and vomiting in paediatric cancer patients, aged 6 months to 17 years.
Data demonstrated that 51% of patients on Emend reached the primary endpoint of achieving complete response, (no vomiting or retching and no use of rescue medication) 25 to 120 hours following the beginning of chemotherapy, compared to 26% of those on placebo. Merck says it plans to file for marketing approval for Emend, which is already a big seller for CINV in adults, in the USA for the new paediatric formulation in the second half of 2014.