FDA Approves Gleevec For Expanded Use in Patients With Rare Gastrointesti... (d clinical study comparing 12 to 36 mont...)

FDA Approves Gleevec For Expanded Use in Patients With Rare Gastrointestinal Cancer

Date:1/31/2012

d clinical study comparing 12 to 36 months of Gleevec. Thirty-six months of Gleevec significantly prolonged overall survival and the time a patient lived without the disease recurring, compared to those receiving 12 months of Gleevec. At 60 months, 92 percent of patients who received 36 months of Gleevec were alive compared to 82 percent of patients who received 12 months of Gleevec.

Gleevec is a pill that should be taken with a meal and a glass of water.

The most common side effects observed in patients receiving Gleevec include swelling (edema), nausea, vomiting, muscle cramps, bone or muscle pain, diarrhea, rash, fatigue, and abdominal pain.

Gleevec was first approved by FDA in May 2001 to treat patients with advanced Philadelphia chromosome positive chronic myeloid leukemia, a blood and bone marrow disease linked to a genetic abnormality.

Gleevec is marketed by Novartis Pharmaceuticals Corp. based in East Hanover, N.J.

For more information:

FDA Approves Gleevec to Prevent Recurrence of Rare Gastrointestinal Cancer (2008)
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116997.htm

FDA Office of Hematology and Oncology Products
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm091745.htm

FDA Approved Drugs: Questions and Answers
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm

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 human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency als
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SOURCE U.S. Food and Drug Administration
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