Millennium Velcade launch
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Shipments of Millennium's proteasome inhibitor Velcade (bortezomib) begin the week of May 19 following accelerated approval May 13 for "treatment of multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy." Approval is based on Phase II data from the 202-patient SUMMIT trial and the 54-patient CREST study (1Pharmaceutical Approvals Monthly Feb. 1, p. 9)...