publication date: Mar. 11, 2016

Xalkori Approved in Metastatic Non-Small Cell Lung Cancer 

 

FDA approved Xalkori (crizotinib) to treat people with metastatic non-small cell lung cancer whose tumors have an ROS-1 gene alteration. Xalkori, sponsored by Pfizer, is the first and only FDA approved treatment for patients with ROS-1 positive NSCLC. FDA previously granted the Xalkori expanded use application breakthrough therapy designation and priority review status.

ROS-1 gene alterations are present in approximately 1 percent of patients with NSCLC. The overall patient and disease characteristics of NSCLC with ROS-1 gene alterations appear similar to NSCLC with anaplastic lymphoma kinase gene alterations, for which crizotinib use was previously approved. Xalkori was approved to treat certain patients with late-stage NSCLC that expresses an abnormal ALK gene in 2011.

“Lung cancer is difficult to treat, in part, because patients have different mutations, some of which are rare,” said Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “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.”

The safety and efficacy of Xalkori for the treatment of patients with ROS-1 positive tumors were evaluated in a multi-center, single-arm study of 50 patients with ROS-1 positive metastatic NSCLC. Results showed 66 percent of participants experienced a complete or partial shrinkage of their NSCLC tumors, an effect that lasted a median of 18.3 months. The safety results of this study were generally consistent with the safety profile of Xalkori … Continue reading 42-10 Xalkori Approved in Metastatic Non-Small Cell Lung Cancer

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