FDA Approves Pembrolizumab for Metastatic SCLC

June 18, 2019 – The FDA has granted an accelerated approval to single-agent pembrolizumab for the treatment of patients with metastatic small cell lung cancer (SCLC) who have disease progression on or after platinum-based chemotherapy and ≥1 other prior line of therapy. The approval is based on pooled results from cohorts of the phase II KEYNOTE-158 and phase Ib KEYNOTE-028 trials, which demonstrated that the PD-1 inhibitor elicited a 19% overall response rate … (leggi tutto)