December 23, 2008 — On December 19, the US Food and Drug Administration (FDA) approved imatinib mesylate (Gleevec, Novartis) to prevent postoperative recurrence of gastrointestinal stromal tumor (GIST).
"Approval of Gleevec offers health care professionals and patients an important new therapeutic option for patients with this uncommon gastrointestinal disease," said Richard Pazdur, MD, FDA director of Oncology Drug Products, Center for Drug Evaluation and Research, in a news release. "It illustrates how the continued study of a once novel drug throughout its product lifecycle can yield new and important uses."
GIST is a rarely occurring cancer originating in the interstitial cells of Cajal, which are autonomic nervous system cells lining and regulating the movement of food and liquid through the stomach and intestines. Incidence of GIST in the United States is approximately 5000 to 6000 new diagnoses each year.
Early diagnosis of GIST is hindered by the nonspecificity of symptoms such as nausea and vomiting. Although surgical resection is the first line of treatment, GIST frequently recurs. Imatinib is indicated postoperatively to help prevent the recurrence of GIST.
A clinical trial showed that treatment with imatinib for 1 year after surgical removal of GIST was more effective than placebo in preventing tumor recurrence. However, optimal treatment duration is still unknown.
Adverse reactions most frequently reported with imatinib were diarrhea, fatigue, nausea, pedal edema, decreased red blood cell counts, rash, vomiting, and abdominal pain.
Imatinib, which is manufactured by Novartis AG in Basel, Switzerland, was first approved by the FDA in 2001. Imatinib was one of the first drugs in a class of agents blocking cellular communications leading to tumor growth.
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