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FDA approves Xalkori to treat ROS1-positive NSCLC
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The FDA today expanded the approval of crizotinib to treat patients with advanced non–small cell lung cancer whose tumors harbor an ROS1 gene alteration.
Crizotinib (Xalkori, Pfizer) is an oral medication that blocks the activity of the ROS1 protein in patients with ROS1-mutated tumors, which may thereby prevent lung cancer from spreading. The agent had already received FDA approval to treat certain patients with late-stage NSCLC that expressed an abnormal ALK gene.
“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 an FDA-issued press release. “The expanded use of Xalkori will provide a valuable treatment option for patients with the rare and difficult to treat ROS1 gene mutation by giving health care practitioners a more personalized way of targeting ROS1-positive NSCLC.”
The agency based the approval on safety and efficacy results from a multicenter, single-arm study composed of 50 patients with ROS1-positive metastatic NSCLC who received crizotinib twice daily.
Overall response rate served as the study’s primary endpoint.
Results showed 66% of patients demonstrated complete or partial tumor shrinkage, which lasted for a median of 18.3 months.
The agent demonstrated a safety profile consistent of that seen in the treatment of patients with ALK-positive metastatic NSCLC.
The most common adverse reactions reported among patients included vision disorders, nausea, diarrhea, vomiting, swelling, constipation, liver problems, fatigue, decreased appetite, upper respiratory infection, and dizziness and numbness or tingling in the hands or feet.
Crizotinib may also cause liver problems, life-threatening or fatal inflammation of the lungs, abnormal heartbeats and partial or complete loss of vision in one or both eyes, according to the FDA.
Prior to this approval, crizotinib received breakthrough therapy designation, fast track status and orphan drug designation for this indication.