Xalkori® Approved for Lung Cancer with ROS-1 Gene Alterations

Xalkori® Approved for Lung Cancer with ROS-1 Gene Alterations.

The United States Food and Drug Administration (FDA) approved Xalkori (crizotinib) as treatment for patients with advanced non-small cell lung cancer (NSCLC) whose cancer has an alteration within the ROS-1 gene. Xalkori is already approved for the treatment of patients with NSCLC that have a mutation in the anaplastic lymphoma kinase (ALK) gene.

Lung cancer causes more cancer-related deaths worldwide than any other type of cancer. Approximately 75% of lung cancers are categorized as NSCLC, referring to certain types of cells in the lung from which the cancer arises.

Within all cellular subgroups of lung cancer, however, researchers have begun to identify several different genetic mutations and/or alterations that are associated with the growth and/or the progression of cancer.

Recently, targeted drugs for lung cancer have been developed that inhibit the cancer-stimulating effects caused by specific genetic mutations. It is now standard for samples of a patient’s lung cancer to undergo genetic testing to determine if the cancer has specific mutations for which anti-cancer drugs have been approved. Results of these tests guide treatment options for patients with NSCLC.

Recent data has indicated that 1% of all patients with NSCLC have mutations within the ROS-1 gene. These specific mutations result in an abnormal protein that is involved in abnormal cellular growth, including the growth and/or development of NSCLC. Through blocking the activity of this abnormal protein, Xalkori reduces the growth and spread of cancer cells.

The clinical trial leading to the approval of Xalkori for ROS-1 positive NSCLC included 50 patients with NSCLC that had spread to distant sites in the body. All patients had mutations within the ROS-1 gene.

  • A complete or partial reduction in cancer was achieved in 66% of patients.
  • The median time to cancer progression was 18.3 months.
  • Treatment with Xalkori was generally well tolerated, with side effects remaining consistent to those seen when Xalkori is used for treatment of ALK-positive NSCLC.

The approval of Xalkori for the treatment of NSCLC with a mutation in the ROS-1 gene represents another example of the fast-growing list of targeted agents in the treatment of NSCLC. Patients with NSCLC should speak with their healthcare provider regarding testing of their cancer for specific genetic mutations.

Reference: United States Food and Drug Administration (FDA). FDA expands use of Xalkori to treat rare form of advanced non-small cell lung cancer. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm490329.htm. Accessed March 11, 2016.

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