Millennium hopes to extend Velcade use

Millennium Pharmaceuticals Inc. said today it plans to file a supplemental new drug application for the use of its Velcade in patients with newly diagnosed multiple myeloma, a form of blood cancer.

Cambridge-based Millennium said it will file the application with the Food and Drug Administration in early 2008 based on encouraging data from a Phase III clinical trial of Velcade in newly diagnosed multiple myeloma patients.

An FDA approval of that application "would double the number of patients eligible to receive the benefit of Velcade," Millennium chief medical officer Nancy Simonian said in a statement. "We are confident that Velcade-based therapies will become the standard of care, since physicians typically use the most active agents in the front-line setting to improve long-term outcomes for patients."

The FDA has previously approved Velcade for multiple myeloma patients who have received at least one prior treatment.

In the United States, more than 50,000 individuals have multiple myeloma, and 20,000 new cases are diagnosed each year, the company said.
(By Chris Reidy, Globe staff)