FDA approves Velcade for patients with previously untreated multiple myeloma

The company’s co-development partner, Johnson & Johnson Pharmaceutical R&D, also has filed a corresponding application with the European Medicines Evaluation Agency.

The current approval was based on an international, multicenter, open-label, active-control trial in previously untreated patients with symptomatic multiple myeloma.

Deborah Dunsire, president and CEO of Millennium, said: “We are excited for patients with previously untreated multiple myeloma, who now can benefit from Velcade, including its ability to deliver a significant increase in overall survival. Velcade treatment also is available for multiple myeloma patients in the second- and third-line settings, where it already is approved.”