Millennium Files sNDA for Velcade for Mantle Cell NHL

Millennium Pharmaceuticals announced it has filed a supplemental new drug application (sNDA) with the U.S. FDA for Velcade (Bortezomib) in the treatment of relapsed or refractory mantle cell lymphoma (MCL), anaggressive subtype of non-Hodgkin's lymphoma (NHL). The filing is based on final data from the Phase II trial, one of the largest multi-center studies in relapsed MCL to date, which showed a 33 percent overall response rate and an eight percent complete response rate. Importantly, the median duration of response was 9.2 months; 13.5 months in patients achieving a complete response. These results are similar to four other Phase II clinical trials that recorded overall response rates of 30 to 40 percent with single-agent Velcade.



Deborah Dunsire, M.D., President and CEO, Millennium says "The results from multiple Phase II mantle cell studies are part of our larger NHL program that includes an ongoing Phase III follicular lymphoma trial. The sNDA filing also represents another step forward to expand the role of Velcade in order to meet the needs of patients with a variety of cancers."



Currently, Velcade has been approved by the FDA for the treatment of multiple myeloma patients who have received at least one prior therapy. To date, over 33,000 multiple myeloma patients have been treated with Velcade worldwide. Earlier this year, Millennium and Johnson & Johnson Pharmaceutical Research & Development, L.L.C., initiated a Phase III clinical trial with Velcade in combination with rituximab(Rituxan/MabThera)in patients with relapsed or refractory follicular lymphoma. News Release