June 5, 2018

Xalkori Receives FDA Breakthrough Therapy Designation for Treatment of Lung Cancer with MET Alterations


The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for Xalkori (crizotinib) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with MET exon 14 alterations with disease progression on or after platinum-based chemotherapy.

The FDA’s Breakthrough Therapy designation is intended to expedite the development and review of a medicine if it is intended to treat a serious or life-threatening disease and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies. The Breakthrough Therapy designation is distinct from the FDA’s other mechanisms to expedite drug development and review.

Lung Cancer Biomarkers & Medicines to Target Them

Not all lung cancer cells are alike. They may differ from one another based on what genes have mutations. By testing an individual’s lung cancer for specific unique biomarkers or genomic alterations doctors can identify genetic mutations or the proteins they produce and offer the most personalized treatment approach utilizing precision medicines.  Precision cancer medicine uses targeted drugs and immunotherapies engineered to directly attack the cancer cells with specific abnormalities, leaving normal cells largely unharmed.  Precision cancer medicines can be used both instead of and in addition to chemotherapy to improve treatment outcomes.

MET is a transmembrane tyrosine receptor kinase which is expressed in several types of cells. In patients with NSCLC, MET exon 14 alterations occur in approximately three percent of NSCLC tumors.1

About Xalkori (crizotinib)

Xalkori is a precision cancer medicine currently approved in the U.S. for the treatment of patients with metastatic NSCLC whose tumors are ALK-positive or ROS1-positive as detected by an FDA-approved test. The Breakthrough Therapy designation for patients with metastatic NSCLC with MET exon 14 alterations was supported by results from an expansion cohort of the Phase 1 PROFILE 1001 study, in which Xalkori showed antitumor activity.2

Individuals with NSCLC not previously tested should discuss biomarker testing with their physician to determine whether newer precision cancer medicines like Xalkori might be a treatment option.


  1. Lovly, C., P. Paik. 2017. MET Exon 14 Skipping Mutations in Lung Cancer. My Cancer Genome https://www.mycancergenome.org/content/disease/lung-cancer/met/343/. (Updated June 15). Accessed May 2018.
  2. Efficacy and safety of crizotinib in patients (pts) with advanced MET exon 14-altered non-small cell lung cancer (NSCLC). Alexander E. Drilon et al. Journal of Clinical Oncology 2016 34:15_suppl, 108-108

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Tags: crizotinib, Lung Cancer, Lung Cancer - Non-Small Cell, MET exon 14 alterations, News, non-small cell lung cancer, nsclc, treatment, Uncategorized, xalkori