FDA Approves Velcade for Treatment of Multiple Myeloma

The Food and Drug Administration (FDA) today announced the approval of Velcade (bortezomib) injection, a new treatment for multiple myeloma, a cancer of the bone marrow. FDA reviewed the application for this drug in less than four months. Velcade is the first in a new class of anticancer agents known as proteasome inhibitors.

Velcade was approved under the accelerated 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 FDA to define the studies that would be conducted.

Velcade is currently being used under controlled study the Myeloma Institute for Research and Therapy.

Fore more information about Velcade, click on the links below:

FDA Approves Velcade for Multiple Myeloma Treatment - Food and Drug Administration

After a Long Struggle, Cancer Drug Wins Approval - New York Times

Multiple Myeloma Research Foundation Clinical Trial

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