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FDA Recognition of Extended Survival with VELCADE® Indicates Important New Progress in Treating the Disease
5 Year Follow-Up of VISTA Trial Shows VELCADE Improves Overall Survival by More than a Year
11.07.11

NORTH HOLLYWOOD, Calif., Nov 07, 2011 (BUSINESS WIRE) -- The International Myeloma Foundation (IMF) -- the oldest and largest foundation dedicated to improving the life and care of myeloma patients -- today said the newly approved label for VELCADE (bortezomib) recognizes improved overall survival for patients who have now been followed for more than five years. This is based on long-term follow up of the landmark, multi-center VISTA trial that demonstrated improved median overall survival of more than a year (13.3 months) when using VELCADE in previously untreated patients. The "label" indicates the official, FDA-approved statements that can be made accurately about a drug.

"Recognition of this survival improvement by the Food and Drug Administration signifies the important progress being made in treating myeloma patients," said Brian G.M. Durie, M.D., chairman and co-founder of the IMF. "Overall survival is the gold standard for patients with cancer, and this longer follow up with VELCADE demonstrates that the benefits we've seen with the newer treatments are continuing long-term."

Myeloma, also called multiple myeloma, is a cancer of cells in the bone marrow that serves as a case study for the issue. Once a rare disease of the elderly, today 20,000 Americans are diagnosed with myeloma each year, and the prevalence of the disease is increasing, with a growing incidence among those who are less than 65 years old.

The VISTA trial compared patients taking VELCADE, melphalan and prednisone, to those treated with just melphalan and prednisone. The patients treated with VELCADE continued to have a statistically significantly longer median overall survival compared to patients on melphalan prednisone alone.

VELCADE for injection is the first in a new class of medicines called proteasome inhibitors that disrupt the life cycle of a cancer cell. It is a product of Millennium: The Takeda Oncology Company.

ABOUT THE INTERNATIONAL MYELOMA FOUNDATION

The International Myeloma Foundation is the oldest and largest myeloma organization, reaching more than 195,000 members in 113 countries worldwide. A 501 (c) 3 non-profit organization dedicated to improving the quality of life of myeloma patients and their families, the IMF focuses on four key areas: research, education, support, and advocacy. To date, the IMF has conducted more than 200 educational seminars worldwide, maintains a world-renowned hotline, and established the International Myeloma Working Group (IMWG), a collaborative research initiative focused on improving myeloma treatment options for patients. The IMF can be reached at (800) 452-CURE (2873). The global website is www.myeloma.org.


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