minate the disease in a third of newly diagnosed patients. About 35 percent of patients who took Velcade with immune- suppressing drugs had a complete remission, compared with 5 percent who were on immune drugs alone, researchers said Sunday at a meeting of the American Society of Hematology in Atlanta. The remissions on Velcade lasted for a median of two years.
Velcade, given intravenously, is approved for patients who relapse after other treatments. The new findings could help Cambridge, Massachusetts-based Millennium market its medicine more widely, and compete with Celgene Corp.'s Revlimid pill. About 19,900 Americans were diagnosed with the disease this year, and almost 11,000 will die from it, according to the American Cancer Society.
"As soon as this is approved, this will become one of the standards of care," for newly-diagnosed patients, said Jesus San Miguel, head of the hematology department at University Hospital of Salamanca, Spain, in an interview. He is the study's lead author.
The results came from a trial of 680 patients, called Vista. Patients either took Velcade in combination with melphalan and prednisone, a pair of immune suppressants, or the immune suppressors alone. The people who enrolled were too elderly, or too frail to withstand a bone marrow transplant, the standard therapy for younger myeloma patients, San Miguel said.
Millennium plans to submit data to U.S. regulators for approval by the end of the year.
About 13 percent of patients on Velcade had nerve damage in their fingers and toes, although the effect was reversible after patients quit taking the drug for two months, San Miguel said. About 14 percent of patients on Velcade, and in the control group, dropped out of the study because of side effects, he said.
Data on whether Velcade can prolong lives is still being collected, San Miguel said. Results so far show that 83 percent of patients on Velcade are alive after two years, compared with 69 percent on the immune suppressants alone.
Although complete remissions usually indicate patients will live longer, it will take several years of follow-up before researchers can perform a formal statistical analysis to show whether Velcade can produce a survival benefit, San Miguel said.
