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The FDA has granted a breakthrough therapy designation to pembrolizumab (Keytruda), an anti-PD-1 therapy, for the treatment of patients with non-small cell lung cancer (NSCLC) who are EGFR mutation- or ALK rearrangement-negative and whose disease has progressed on or following platinum-based chemotherapy.

Treatment with crizotinib (Xalkori) demonstrated an overall response rate (ORR) of 72% in patients with ROS1-rearranged non–small cell lung cancer (NSCLC), according to phase I data presented at the 2014 ESMO Congress and published in The New England Journal of Medicine.