Recent approvals and the pipeline
December 2016—Pembrolizumab (Keytruda) is now FDA approved as monotherapy for patients with untreated metastatic NSCLC, both squamous and nonsquamous histologies, that express PD-L1 at a high level of 50 percent or more, says Dr. Roger Dansey, who headed up Keytruda development at Merck Research Laboratories. “We do not have data at this point that would say whether a cutpoint lower than 50 percent in the first-line setting would be of equal value in terms of response to Keytruda,” he says.