WASHINGTON, May 6 (Xinhua) -- The U.S. Food and Drug Administration (FDA) on Wednesday approved Tabrecta for the treatment of adult patients with non-small cell lung cancer (NSCLC) that has spread to other parts of the body.
Tabrecta is the first FDA-approved therapy to treat NSCLC with specific mutations. The FDA also approved the FoundationOne CDx assay, a comprehensive genomic profiling test, as a companion diagnostic for Tabrecta.
"Lung cancer is increasingly being divided into multiple subsets of molecularly defined populations with drugs being developed to target these specific groups," said Richard Pazdur, director of the FDA's Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA's Center for Drug Evaluation and Research.
"Tabrecta is the first approval specifically for the treatment of patients with non-small cell lung cancer whose tumors have mutations that lead to MET exon 14 skipping. This patient population now has an option for a targeted therapy, which they didn't have prior to today," he said.
According to the FDA, Tabrecta is a kinase inhibitor, meaning it functions by blocking a key enzyme that results in helping to stop the tumor cells from growing.
The FDA said it approved Tabrecta based on the results of a clinical trial involving patients with NSCLC with mutations that lead to MET exon 14 skipping, epidermal growth factor receptor wild-type and anaplastic lymphoma kinase negative status, and at least one measurable lesion. Enditem