FDA Lowers Pembrolizumab PD-L1 Cutoff in NSCLC, Expands Approval to Stage III

April 11, 2019 – The FDA has expanded the approval for pembrolizumab monotherapy for the frontline treatment of patients with stage III non–small cell lung cancer (NSCLC), who are ineligible for surgery or definitive chemoradiation, or metastatic NSCLC, with a PD-L1 expression (tumor proportion score [TPS]) level of ≥1% and do not harbor EGFR or ALK aberrations. The approval is based on findings from the phase III KEYNOTE-042 trial, which showed that frontline … (leggi tutto)