Source: DGNews  |  Posted 3 years ago

NEW YORK -- June 23, 2008 -- The US Food and Drug Administration has approved bortezomib (Velcade) for patients with previously untreated multiple myeloma. The new indication offers earlier treatment options for patients.

The current approval was based on the VISTA1 (Velcade as Initial Standard Therapy in Multiple Myeloma: Assessment With Melphalan and Prednisone) trial -- an international, multicentre, open label, active-control trial in previously untreated patients with symptomatic multiple myeloma.

Patients (N = 682) were randomised to receive either nine 6-week cycles of oral melphalan plus prednisone (n = 338) or oral melphalan plus bortezomib (n = 344). Patients received melphalan 9 mg/m² plus prednisone 60 mg/m² QD for 4 days every 6 weeks or the same melphalan schedule with bortezomib 1.3 mg/m² IV on days 1, 4, 8, 11, 22, 25, 29, and 32 of every 6-week cycle for 4 cycles then once weekly for 4 weeks on days 1, 8, 22, and 29 of every 6-week cycle for 5 additional cycles. The median age of patients for both groups was 71 years. Demographics and baseline disease characteristics were similar between the 2 groups.

"The VISTA1 trial showed 30% complete remission rate with bortezomib compared to 4% for the control arm. Patients treated with bortezomib also experienced a survival benefit," said senior investigator Paul Richardson, MD, Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute, Boston, Massachusetts.

In the United States, bortezomib is indicated for the treatment of patients with multiple myeloma and for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.

SOURCE: Millennium Pharmaceuticals