US FDA expands the approval of Keytruda® in Stage III NSCLC

Photo credit: Victor Segura Ibarra and Rita Serda Merck (NJ, USA) has recently announced that the US FDA approved an expanded label for pembrolizumab as monotherapy for the first-line treatment of patients with Stage III non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC, and whose tumors express PD-L1 (tumor proportion score ≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.This label extension is based on the positive results of the Phase III KEYNOTE-042 trial, a randomized, multi-center, open-label, active-controlled trial enrolling 1274 patients. Patients were...