
The Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency (EMA), has recommended the approval of Keytruda (pembrolizumab) in combination with chemotherapy for the initial treatment of metastatic squamous non-small cell lung cancer (NSCLC) patients.
The CHMP’s opinion was based on clinical evidence from the KEYNOTE-407 Phase 3 trial (NCT02775435), in which the combination significantly extended patients’ lives compared to chemotherapy alone. It now will be reviewed by the European Commission for a final decision regarding approval, which is expected by April.
“We are pleased by today’s positive opinion from the CHMP, which brings us one step closer to potentially expanding our lung cancer indications in Europe to include first-line combination therapy for patients with metastatic squamous non-small cell lung cancer, regardless of PD-L1 expression,” Roy Baynes said in a press release. Baynes is senior vice president and head of global clinical development, and chief medical officer, Merck Research Laboratories.
Source: Immuno-Oncology News







