Merck, called MSD outside of Canada and the U.S., recently announced that its new Keytruda (pembrolizumab) treatment for advanced or metastatic non-small cell lung cancer (NSCLC) has gained approval from the European Commission (EC).
The EC bases its new approval on the evidence of trials that show the treatment gives previously treated patients superior survival rates over chemotherapy.
“This approval provides an important new treatment regimen for patients in Europe with advanced lung cancer, one of the most common and challenging cancers,” Dr. Roger Dansey, senior vice president and therapeutic area head of oncology late-stage development, Merck Research Laboratories, said. “In the Keynote-010 trial, patients with advanced lung cancer who had failed prior regimens experienced improved overall survival when treated with Keytruda as compared with those treated with traditional chemotherapy.”
Keytruda is Merck’s anti-PD-1 therapy. It is specifically applicable to patients who have tumors that show PD-L1 expressions. These patients must also have already received a minimum of one earlier chemotherapy regimen.
“The survival benefit for Keytruda observed in previously-treated patients who express PD-L1 is promising,” Dr. Luis Paz-Ares, chair of the medical oncology department at Hospital Universitario in Madrid, said. “There is a significant unmet need for lung cancer patients, and with this approval, we now have a new personalized treatment option which uses biomarker testing to predict which patients are most likely to benefit from treatment.”
