Millennium files supplemental NDA for Velcade injection

By Elaine Rigoli

Tampa, Fla., June 9 - Millennium Pharmaceuticals, Inc. said Friday is has filed a supplemental New Drug Application with the Food and Drug Administration for Velcade in the treatment of relapsed or refractory mantle cell lymphoma (MCL), an aggressive subtype of non-Hodgkin's lymphoma that is not curable.

Millennium said the filing is based on final data from the phase 2 Pinnacle trial, one of the largest multi-center studies in relapsed MCL to date, which showed a 33% overall response rate and an 8% complete response rate.

The median duration of response was 9.2 months; it was 13.5 months in patients achieving a complete response.

These results are similar to four other phase 2 clinical trials that recorded overall response rates of 30% to 40% with single-agent Velcade, according to a news release.

Currently, Velcade is FDA-approved for the treatment of multiple myeloma patients who have received at least one prior therapy.

Millennium Pharmaceuticals is a Cambridge, Mass.-based biopharmaceutical company.

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