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Afinitor(R) Phase II Data Show Positive Results for Patients With Multiple Types of Lymphoma, Leading to Phase III Trial
Date:6/8/2009

-Hodgkin's lymphoma (63% ORR), Hodgkin's disease (53% ORR), follicular lymphoma (50% ORR), mantle cell lymphoma (32% ORR), DLBCL (30% ORR) and small lymphocytic lymphoma (18% ORR)(1).

Patients received everolimus 10 mg daily and were evaluated monthly. Dose reductions to 5 mg daily and 5 mg every other day were permitted. Response was assessed after two cycles of treatment and periodically thereafter. Patients received a median of three cycles(1). Overall, everolimus was well tolerated. The most commonly reported adverse events (grade 3 or 4; >10% patients) in this heavily pretreated population included anemia, neutropenia and thrombocytopenia(1).

About non-Hodgkin's lymphoma and Hodgkin's disease

Non-Hodgkin's lymphoma and Hodgkin's disease manifest in the cells of the lymphatic system, which is composed of lymphoid tissue, lymph vessels and lymph fluid that help the body filter out bacteria and fight disease. Since lymphatic tissue is located throughout the body, NHL and Hodgkin's disease can start almost anywhere(2,7,8). The most recent data indicate that more than 300,000 new cases of NHL develop around the world each year(9).

About Afinitor

Afinitor has been approved by the US Food and Drug Administration (FDA) as the first oral, daily therapy (5 mg and 10 mg tablets) to treat advanced kidney cancer after failure of treatment with sunitinib or sorafenib. Recently, the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion supporting EU approval of Afinitor to treat patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with vascular endothelial growth factor (VEGF)-targeted therapy.

In cancer cells, Afinitor continuously targets mTOR, a protein that acts as a central regulator of tumor cell division, blood vessel growth and cell metabolism. Novartis has also filed regulatory su
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SOURCE Novartis
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