Millennium Receives FDA Approval for New Velcade Indication

The FDA has approved Millennium Pharmaceuticals' supplemental new drug application for Velcade, clearing the way for the drug to be prescribed to patients with multiple myeloma (MM) who have received at least one prior therapy.

Millennium said the new indication doubles the number of U.S. patients who could potentially benefit from Velcade (bortezomib) to approximately 22,000. The company received initial approval for Velcade in 2003 for treatment of relapsed refractory MM.