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article imageXalkori gets rapid FDA approval for treating lung cancer

By Kathleen Blanchard     Aug 26, 2011 in Health
The U.S. FDA has approved a drug for treating lung cancer that could change the way cancer treatment is approached. The drug turns off a specific gene that drives some forms of non-small cell lung carcinoma.
Approval of the drug Xalkori is generating some excitement and opens the door to personalized cancer therapy. The medication, generically known as crizotinib, is approved for treatment of non-small cell lung carcinoma associated with the abnormal anaplastic lymphoma kinase (ALK) gene, following a six month review of two clinical trials.
At the same time the FDA also approved a genetic testing kit to identify patients with advanced non-small cell lung cancer - NSCLC - who would benefit from the twice a day medication, which can be taken by mouth.
Xalkori is marketed by the drug company Pfizer. The kit, which determines whether a patient has the abnormal ALK gene, is made by Abbott Molecular.
Richard Pazdur, MD, director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research said in a press release. "Targeted therapies such as Xalkori are important options for treating patients with this disease and may ultimately result in fewer side effects."
Researchers have been seeking therapies that genetically target the various types of cancer. Genotyping cancer and developing specific treatments based on tumor characteristics is a novel approach advocated by oncology specialists.
The FDA gave the nod of approval to crizotinib through their expedited six month priority review program that identifies drugs that can provide significant advantage or for which no other treatment exists.
Seven percent of non-small cell lung carcinomas are the result of the altered anaplastic lymphoma kinase (ALK) gene. Xalkori switches off the gene that drives ALK mutation NSCLC.
“Overall, lung cancer is responsible for more deaths each year worldwide than any other type of cancer. Xalkori is an advance in the treatment of this devastating illness, providing a new therapeutic option for a subset of patients with the disease,” said Ian Read, president and chief executive officer of Pfizer.”
Dr. Joan Schiller, president of National Lung Cancer Partnership and chief of Hematology/Oncology, University of Texas Southwestern Medical Center said, “We strongly encourage lung cancer patients to talk to their oncologists about molecular tumor testing. By having a full understanding of the molecular biology of their tumor, patients and physicians can make well-informed treatment decisions.”
Patients prescribed Xalkori can call 1-877-744-5675 for assistance accessing the medication. For more information about the FDA-approved ALK test, call (855) TEST-ALK (837-8255). The drug is available from specialty pharmacies.
More about Xalkori, Lung cancer, ALK gene, Pfizer
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