Millennium/J&J's FDA approval for Velcade

The US Food and Drug Administration has given approval to Velcade (bortezomib), an injection for the treatment of multiple myeloma, developed in partnership between Japan's Takeda, its US affiliate Millennium Pharma and US health care major Johnson & Johnson.

The current approval was based on a global, multicenter, open label, active-control trial in previously untreated patients with symptomatic multiple myeloma. Patients were randomized to receive either nine, six-week cycles of oral melphalan plus prednisone or MP plus Velcade. Time-to-progression was the primary efficacy endpoint. Overall survival, progression-free survival and response rate were secondary endpoints. A total of 682 patients were randomized: 338 to receive MP and 344 to get the combination of bortezomib plus MP. Results showed a 30% rate of complete remission compared to just 4% for the control arm. The safety profile of Velcade in combination with MP was consistent with the known safety profiles of both Velcade and MP.