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FDA Approves Xalkori with Companion Diagnostic for a Type of Late-stage Lung Cancer
Date:8/26/2011

visual field defects. Xalkori use has also been associated with inflammation of the lung tissue (pneumonitis), which can be life-threatening. Patients with treatment-related pneumonitis should permanently stop treatment with Xalkori. The drug should not be used in pregnant women.

In July 2011, FDA issued a draft guidance industry on the agency's policy for reviewing a companion diagnostic and the corresponding drug therapy. The guidance is currently available for public comment.

Xalkori is marketed by New York City-based Pfizer. The Vysis ALK Break Apart FISH Probe Kit is marketed by Abbott Molecular Inc. of Des Plaines, Ill.

For more information:

FDA: Office of Oncology Drug Products

http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm091745.htm

FDA: Office of In Vitro Diagnostics

http://www.fda.gov/medicaldevices/productsandmedicalprocedures/invitrodiagnostics/default.htm

FDA: Draft Guidance – In Vitro Companion Diagnostic Devices

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm262292.htm

FDA: Approved Drugs: Questions and Answers

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm

NCI: Non-small cell lung cancer

http://www.cancer.gov/cancertopics/pdq/treatment/non-small-cell-lung/Patient/page1

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of huma
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SOURCE U.S. Food and Drug Administration
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