The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) holds a positive opinion regarding Keytruda (pembrolizumab), which is designed to treat metastatic non-small cell lung cancer (NSCLC).
“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,” Dr. Roger Dansey, Merck Research Laboratories senior vice president and therapeutic area head for oncology late-stage development, 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.”
This decision was based on the positive results from the Keynote-024 study, which evaluated Keytruda versus platinum-containing chemotherapy. The phase 3 trial compared the two treatments in patients with squamous and non-squamous metastatic NSCLC. Participants had not received chemotherapy treatment previously.
Lung cancer is the leader in cancer deaths worldwide; 85 percent of all lung cancers are NSCLC. Patients diagnosed with stage-four lung cancer face an estimated 2 percent five-year survival rate.
