FDA Expands Approval of PD-L1 IHC 22C3 pharmDX Assay in NSCLC

April 17, 2019 – The FDA has expanded the approval of the PD-L1 IHC 22C3 pharmDX assay, allowing the test to be used as a companion diagnostic to identify more patients with stage III or metastatic non–small cell lung cancer (NSCLC) who can undergo first-line treatment with pembrolizumab. The expanded indication coincides with the recent FDA approval of single-agent pembrolizumab for the first-line treatment of patients with stage III NSCLC, who are … (leggi tutto)