FDA Approves Single-Agent Pembrolizumab or Plus Chemo for Frontline HNSCC

June 11, 2019 – The FDA has approved pembrolizumab for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma as monotherapy whose tumors express PD-L1 (composite positive score [CPS] ≥1) or in combination with platinum and fluorouracil (FU) for this patient population, irrespective of PD-L1 expression. The decision is based on findings from the phase III KEYNOTE-048 trial, in which single-agent … (leggi tutto)