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"VELCADE based therapies have unprecedented complete remission rates andsurvival benefits in multiple myeloma," said Nancy Simonian, M.D., ChiefMedical Officer, Millennium. "Data to be presented at ASH from three large,randomized Phase III trials will support the expansion of our market-leadingtherapy into the front-line multiple myeloma setting."
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Front-Line Multiple Myeloma
Data to be featured at ASH will continue to build on the growing body ofevidence that supports the use of VELCADE in both newly diagnosed transplantand non-transplant patients. The data from a total of 20 Phase II and PhaseIII front-line studies will highlight the efficacy of VELCADE based therapieswith consistently high CR and survival benefits. Phase III presentationhighlights are scheduled to include:
Relapsed/Refractory Multiple Myeloma
Data will be presented from 23 studies of VELCADE based therapies for thetreatment of relapsed MM. These data, including settings where VELCADE isused for retreatment and in patients with renal impairment, support theimportance of adding VELCADE in combination with numerous emerging andestablished agents.
Non-Hodgkin's Lymphoma
VELCADE is the only approved therapy in previously treated mantle celllymphoma (MCL), the most aggressive form of NHL. Data will be featured onVELCADE in various subsets of NHL, including follicular and the use ofbiomarkers as a predictor of patient response.
About Multiple Myeloma
Multiple myeloma is the second most common hematologic malignancy andalthough the disease is predominantly a cancer of the elderly (the median ageof onset is 70 years of age), recent statistics indicate both increasingincidence and younger age of onset. In the U.S., more than 50,000 individualshave MM and 20,000 new cases are diagnosed each year. Worldwide there areapproximately 74,000 new cases and over 45,000 deaths annually.
About Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma
NHL is the most common hematological cancer, the fifth leading cause ofcancer death and the second fastest growing form of cancer in the U.S. Theprevalence of NHL in the U.S. is approximately 400,000 patients, includingapproximately 200,000 patients with diffuse large B-cell lymphoma, 100,000patients with follicular and marginal zone lymphoma and 10,000 with MCL. Thereare approximately 54,000 new cases of NHL diagnosed in the U.S. per year, and19,000 deaths are attributed to the disease annually.
MCL is an aggressive, rapidly progressive subtype of NHL, and is notcurable with standard treatment. The median life expectancy for a patient withMCL following first relapse is one to two years.
About VELCADE
VELCADE is being co-developed by Millennium Pharmaceuticals, Inc. andJohnson & Johnson Pharmaceutical Research & Development, L.L.C. Millennium isresponsible for commercialization of VELCADE in the U.S., Janssen-Cilag isresponsible for commercialization in Europe and the rest of the world. JanssenPharmaceutical K.K. is responsible for commercialization in Japan. For alimited period of time, Millennium and Ortho Biotech Inc. are co-promotingVELCADE in the U.S. VELCADE is approved in more than 80 countries worldwide.
In the U.S., VELCADE is indicated for the treatment of patients withmultiple myeloma who have received at least one prior therapy. VELCADE isindicated for the treatment of patients with mantle cell
