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May 13, 2003 Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA FDA Approves Velcade for Multiple Myeloma Treatment 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 drugs commercial sponsor worked closely with FDA to define the studies that would be conducted. "As a result of close collaboration among the company, The National Cancer Institute, and FDA in the development and review of the drug, FDA was able to make this novel therapy available sooner to help many thousands of patients suffering from multiple myeloma." said FDA Commissioner Mark B. McClellan, M.D., Ph.D. "The approval of Velcade illustrates FDAs commitment to providing patients with access to safe and effective drugs as quickly as possible." | |
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