June 27, 2016
Merck, known as MSD outside the United States and Canada, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, for treating locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults who have received at least one prior chemotherapy regimen and whose tumors express PD-L1. This CHMP positive opinion for KEYTRUDA will now be reviewed by the European Commission for marketing authorization in the European Union (EU).
“This news marks an important step in making KEYTRUDA available for appropriate patients suffering from locally advanced or metastatic non-small cell lung cancer. We are grateful to patients and investigators around the world who participated in these studies and who are helping to advance this important new treatment,” said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories.
Data supporting the CHMP positive opinion were based on findings from two studies, KEYNOTE-001, which assessed overall response rates (ORR), and KEYNOTE-010, a pivotal study assessing overall survival (OS).KEYTRUDA® (pembrolizumab) of Merck Receives Positive CHMP Opinion for the Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)last edit: 2016-06-29T18:08:58+00:00da