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FDA grants breakthrough therapy designation to Xalkori for ROS1-positive NSCLC
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The FDA granted breakthrough therapy designation to crizotinib for the treatment of patients with ROS1-positive non–small cell lung cancer, according to a press release from the drug’s manufacturer.
Crizotinib (Xalkori, Pfizer) — a tyrosine kinase inhibitor — was approved in 2011 for the treatment of patients with NSCLC who harbor ALK mutations.
The FDA based the breakthrough therapy designation on results of a global phase 1 study which evaluated crizotinib in 50 patients with ROS1-positive advanced NSCLC. Results — published in November 2014 in The New England Journal of Medicine —demonstrated anti-tumor activity in patients who received crizotinib.
The safety profiles of crizotinib were similar among patients with ROS1-rearranged and ALK-positive advanced NSCLC, according to the press release.
“We are excited that the FDA has granted Breakthrough Therapy designation for Xalkori as a potential treatment for patients with ROS1-positive NSCLC,” Mace Rothenberg, MD, chief medical officer for Pfizer Oncology, said in a press release. “Xalkori pioneered precision medicine for ALK-positive metastatic NSCLC, and ROS1 represents a second molecular subgroup of NSCLC in which Xalkori has demonstrated a level of anti-tumor activity that can potentially make a real difference for patients.”