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FDA Approves Velcade for Myeloma

FDA Approves Velcade for Myeloma

WASHINGTON—The FDA has approved Millennium Pharmaceuticals’ Velcade (bortezomib)
injection for patients with multiple myeloma that has relapsed after two
prior treatments and has shown resistance to the last treatment. Velcade was
granted priority review by the FDA on March 10, 2003, and was approved
approximately 2 months later. It has been just 4½ years from the first human
dose to FDA approval.

Proteasome Inhibitor

Velcade is the first in a new class of anticancer agents known as
proteasome inhibitors. 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.

"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."

FDA evaluated the safety and efficacy of Velcade based on the phase II
open-label single-arm SUMMIT study of 202 patients with relapsed and
refractory multiple myeloma who had received at least two prior therapies
(median, six). Patients had advanced disease, with 91% refractory to their
most recent therapy prior to study entry.

Out of 188 patients evaluated for response, 27.7% showed a response to
Velcade, lasting a median of 1 year. Significantly, 17.6% of patients
experienced a clinical remission by Southwest Oncology Group (SWOG) criteria.
Median survival was 16 months (range, less than 1 month to more than 18
months). The smaller CREST trial in 54 patients with relapsed multiple
myeloma showed similar response rates. [See ONI February 2003, page

As of yet, there are no controlled trials of Velcade demonstrating
clinical benefit such as improvement in survival. To address this issue,
Millennium will perform additional studies after approval, including the
completion of an ongoing study and an additional study comparing Velcade with
standard therapy.


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