According to a recent Merck announcement, Keytruda has received a positive opinion and a recommendation for approval from the European Medicines Agency (EMA).
Keytruda received the recommendation due to its ability to treat metastatic non-small cell lung cancer (NSCLC) in adult patients who have tumors with increased PD-L1 expressions and no EGFR or ALK positive tumor mutations.
“Lung cancer is one of the leading causes of death in the EU, so today’s news is an important step forward for many patients in Europe,” Merck Research Laboratories Senior Vice President and Therapeutic Area Head Dr. Roger Dansey said. “If approved, patients with metastatic non-small cell lung cancer with high PD-L1 expression could receive Keytruda instead of chemotherapy as their initial treatment. We are committed to working collaboratively with governments and other stakeholders to ensure that Keytruda will be made available to patients in Europe as quickly as possible.”
The European Commission will now review the recommendation for Keytruda by the EMA and decide whether or not to give the medication marketing authorization in the European Union (EU).
A final decision is expected to be made in the first quarter of 2017.
