The FDA has issued breakthrough therapy designation to pembrolizumab for treating patients with epidermal growth factor receptor mutation-negative and anaplastic lymphoma kinase rearrangement-negative non–small cell lung cancer who have received at least one prior platinum-containing chemotherapy, Merck announced.

The FDA used interim efficacy and safety results from an ongoing phase 1b KEYNOTE-001 study of pembrolizumab (Keytruda) and data presented at the European Society of Medical Oncology 2014 Congress to base the designation, which is intended to expedite development and review of drugs to treat serious or life-threatening conditions.