The U.S. Food and Drug Administration announced last month that they have granted regular approval to the anti-cancer drug Xalkori, known generically as crizotinib, to treat patients with late-stage, metastatic non-small cell lung cancers (NSCLC) who express the abnormal anaplastic lymphoma kinase (ALK) gene. The FDA had previously granted accelerated approval for the drug that may also benefit mesothelioma patients.
In order to determine if the drug will be an effective therapy, a genetic test will be performed to identify the ALK fusion gene. This test must be used to identify the ALK marker in a patient prior to a physician prescribing the twice-a-day pill.
“XALKORI has dramatically changed the treatment landscape for patients with advanced ALK-positive NSCLC,” said Garry Nicholson, president and general manager, Pfizer Oncology Business Unit, in a press release announcing the approval. “Achievement of this milestone underscores Pfizer’s commitment to provide physicians with effective cancer therapies for their patients.”
Pleural mesothelioma is a rare form of lung cancer that invades the outer lining of the lungs called the mesothelium. The only known cause of mesothelioma is through inhalation or ingestion of airborne asbestos fibers. The cancer is a diffuse malignancy that blurs the boundaries between malignant tissue and healthy tissue. Lung cancer, however, is characterized by individual tumor masses with clear boundaries. Even with this difference between the two pulmonary cancers, the treatments are often very similar.
Pfizer, the maker of Xalkori, reports that about 3%-5% of people with NSCLC may test positive for the ALK fusion gene. There is a potential that the marker is also present in certain pleural mesothelioma cases making it a new treatment option for the disease.
According to the Nov. 20 press release from the FDA, “the approval was based on demonstration of superior progression-free survival (PFS) and overall response rate (ORR) for crizotinib-treated patients compared to chemotherapy in patients with ALK-positive NSCLC with disease progression after platinum-based doublet chemotherapy.”
Crizotinib, and the associated genetic test, is another step towards personalized cancer treatment that could benefit the 2,000 to 3,000 Americans diagnosed with mesothelioma each year. Personalized care targeted to a patient’s unique characteristics and genetic makeup optimizes the potential for success of the treatment.
Read more: http://www.mesotheliomahelp.net/blog/2013/12/pfizers-xalkori-granted-full-fda-approval-lung-cancer-treatment-potential-treatment-mesothelioma-patients#ixzz2nYkCzfxy 
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