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Published on 9/19/2006 in the Prospect News Biotech Daily.

Novartis: Glivec approved in E.U. for leukemia, solid cancer tumor

By Lisa Kerner

Charlotte, N.C., Sept. 19 - Novartis received additional European Union approvals for Glivec (imatinib) for a progressive form of leukemia and hard-to-treat solid cancer tumors.

"These two new indications underscore how cancers and diseases of different origin and location share common molecular characteristics that can often respond to the same targeted treatment," president of Novartis Oncology David Epstein said in a news release.

The drug, originally approval for treatment of patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia, is now approval for use in adult patients with newly diagnosed Ph+ acute lymphoblastic leukemia.

Glivec was also approved for treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans who are not eligible for surgery.

Submissions in the European Union for three other rare diseases (hypereosinophilic syndrome, systemic mastocytosis and myelodysplastic/myeloproliferative diseases) are under review.

Novartis is a pharmaceutical company based in Basel, Switzerland.


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