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June 2003 Volume 5, Issue 6:
FDA Approves VELCADE® for the Treatment of Relapsed and Refractory Multiple Myeloma
06.05.03

This issue of Myeloma Today is sponsored in part by an unrestricted educational grant from Novartis Pharmaceuticals.

On May 13, 2003, the U.S. Food and Drug Administration (FDA) approved VELCADE� (bortezomib) injection (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 FDA reviewed the application for VELCADE in less than four months. VELCADE is the first in a new class of anticancer agents known as proteasome inhibitors. It was approved under the accellerated approval program. The program helps make promising products for serious or life threatening diseases available earlier in the development process by allowing approval to be based on a promising effect of the drug, such as tumor shrinkage, before there is actual evidence of improved survival or other clinical benefit. The drug�s commercial sponsor worked closely with the FDA to define the studies that would be conducted. 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.

To learn about the development of Velcade�, read the interview with the doctor who discovered the drug, Julian Adams, PhD.

View the full Millennium Pharmaceuticals, Inc. Velcade� press release.

View the FDA press release. To contact the FDA's Consumer Inquiries Line, please call (888) INFO-FDA.

The FDA's US package insert (full prescribing information, clinical trial information, safety, dosing, drug-drug interactions and contraindications).


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