“The FDA today granted breakthrough therapy designation and priority review to pembrolizumab for the first-line treatment of patients with advanced non–small cell lung cancer whose tumors express PD-L1, according to the drug’s manufacturer.
“The phase 3 KEYNOTE-024 study — designed to compare pembrolizumab (Keytruda, Merck) monotherapy with standard chemotherapy — included 305 patients with advanced disease.
“All patients’ tumors expressed high levels of PD-L1, defined as a tumor proportion score of 50% or more, and no patients had received prior systemic chemotherapy for their disease.”
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