The recommendation is for treating NSCLC patients whose tumors have high PD-L1 expression without any EGFR or ALK positive tumor mutations.
The CHMP’s positive opinion came through from the data collected from the phase 3 Keynote-024 trial of pembrolizumab.
The drug compound recorded superior overall survival and progression-free survival in comparison to chemotherapy in patients during the trial.
Merck Research Laboratories senior vice president and therapeutic area head, oncology late-stage development Dr. Roger Dansey said: “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. 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 CHMP recommendation before deciding on giving a marketing authorization approval for Keytruda in the European Union.
It is expected that the regulator will likely to decide on the approval in the first quarter of next year.
Till date, the humanized monoclonal antibody has approval in Europe for the second-line treatment of patients with locally advanced or metastatic NSCLC whose tumors express PD-L1 and have also received at least one prior chemotherapy regimen.
Prior to receiving Keytruda, patients having EGFR or ALK positive tumor mutations should also have received targeted therapy.