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Myeloma Minute Special Edition- FDA Approves Velcade for Myeloma Treatment

On May 13, 2003 the U.S. Food and Drug Administration approved bortezomib (VELCADE™ , Millennium Pharmaceuticals, Inc.) for the treatment of multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy.

The following is excerpted from the Millennium press release announcing the FDA approval of VELCADE™ :

Cambridge, Mass., May 13, 2003 - Millennium Pharmaceuticals, Inc. today received approval from the U.S. Food and Drug Administration (FDA) to market VELCADE for the treatment of multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. The effectiveness of VELCADE is based on response rates. There are no controlled trials demonstrating a clinical benefit such as an improvement in survival. VELCADE, the first of a new class of medicines called proteasome inhibitors, is the first treatment in more than a decade to be approved for patients with multiple myeloma - a cancer of the blood.

"The FDA approval of VELCADE represents a major advance in our fight against multiple myeloma," said Kenneth Anderson, M.D., from Dana-Farber Cancer Institute in Boston, Mass. "With its new and unique mechanism of action of inhibiting the proteasome, VELCADE is different from traditional chemotherapies and represents a new treatment option for patients."

"Millennium was established with the goal of using innovative science to develop novel products that would address the unmet medical needs of patients," said Mark Levin, chief executive officer and chairperson of Millennium. "Our success in bringing VELCADE to patients so rapidly reflects the high level of collaboration among many partners, both internally and externally. Moving forward, Millennium will continue its mission of developing breakthrough products that make a difference in patients' lives."

VELCADE and proteasome inhibition represent a completely new approach to treating multiple myeloma. The development of this product is based on the Company's deep understanding of cancer disease pathways and the effect of proteasome inhibition on those pathways. The proteasome is an enzyme complex that exists in all cells and plays an important role in degrading proteins that control the cell cycle and cellular processes. By blocking the proteasome, VELCADE disrupts numerous biologic pathways, including those related to the growth and survival of cancer cells.

Approval Links:

  • FDA's Consumer Inquiries Line: 888-INFO-FDA

Historical Links:

  • PS-341: The Patient Experience
    August 30, 2002. A compilation of participant interviews conducted by Dr. Durie during the recent Phase II trials provide a better understanding of the impact of VELCADE™ therapy on patients with relapsing/refractory myeloma.

Other Important Links:

  • IMF Hotline: 800-452-CURE (800-452-2873) between 9 am and 4 pm PST from the US and Canada.

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