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FDA approves new cancer drug Crizotinib

Posted in Drug Studies, Public Health

In an article published from the Oncology Report Digital Network by Elizabeth Mechcatie, titled “FDA Grants Full Approval to Crizotinib for NSCLC Indication”, the Food and Drug Administration announced that a new drug was approved for the treatment of small cell lung cancer.  Crizotinib is a kinase inhibitor that works by blocking the actions of cancer cells, and studies that have been done on this new medication showed the drug was able to delay progression of the cancer better than the traditional chemotherapy used to treat lung cancer.

Author Elizabeth Mechcatie states “The drug approval was based on objective response rates of 50% and 61% in two single-arm open-label trials; full approval was contingent on providing evidence that confirmed the clinical benefits.”  In all, 347 patients were studied in order to determine which form of treatment (crizotinib or chemotherapy) was more effective.  Some negative effects associated with crizotinib that were seen in 25 percent of the patients were fatigue, vomiting, constipation, and diarrhea.

Further safety evaluations of the new drug found that the most common adverse events were pulmonary embolisms (blockage of an artery that supplies blood to the lungs) and other respiratory distress complications.  Blockage of blood to the lungs can lead to cardiac arrest which can be fatal if the appropriate steps are not quickly taken.  The heart receives blood with oxygen from the lungs, and cells of the heart that do not receive oxygen will die and will not grow back.  Crizotinib was able to delay progression of the cancer by 7.7 months compared to chemotherapy which was able to delay progression by only 3 months.