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FDA Approves Crizotinib for ROS1-Positive NSCLC

Dr. Richard Pazdur

Richard Pazdur, MD

The FDA has approved crizotinib (Xalkori) as a treatment for patients with ROS1-positive metastatic non–small cell lung cancer (NSCLC), based on the demonstration of substantial efficacy in a phase I study.

The approval was based on data from 50 patients with ROS1-positive NSCLC, in which the overall response rate (ORR) was 66% with a median duration of response of 18.3 months by independent review. The approval was preceded by a breakthrough therapy designation and arrived approximately 1 month ahead of the deadline set under the Prescription Drug User Fee Act.

“Lung cancer is difficult to treat, in part, because patients have different mutations, some of which are rare,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a statement. “The expanded use of Xalkori will provide a valuable treatment option for patients with the rare and difficult to treat ROS-1 gene mutation by giving health care practitioners a more personalized way of targeting ROS-1 positive NSCLC.” Click here to read the full article at

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