Novartis' Zykadia, a treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive, has been approved for expanded use by the U.S. Food and Drug Administration.
Zykadia, a selective inhibitor of anaplastic lymphoma kinase (ALK), is approved in more than 69 countries across the globe.
The drug first received accelerated approval in 2014 for ALK-positive metastatic NSCLC patients who progressed on or are intolerant to crizotinib. In 2017, Zykadia was granted breakthrough designation by the FDA, this time as a first-line treatment for ALK-positive metastatic NSCLC patients with metastases to the brain.
"Today's approval represents the next step in the development of Zykadia as a treatment option for ALK-positive metastatic NSCLC, bringing this important medication to a patient population where a need still exists," Novartis Oncology CEO Bruno Strigini said in a statement. "At Novartis, we are tireless in our pursuit of developing novel medicines to treat lung cancer, and the first-line approval of Zykadia for ALK-positive metastatic NSCLC illustrates our commitment to cancer patients."
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