Millennium Pharmaceuticals, Inc. (Cambridge, Massachusetts) Files sNDA For VELCADE(R) (Bortezomib) For Injection In Treatment Of Relapsed Or Refractory Mantle Cell Lymphoma

CAMBRIDGE, Mass., June 9 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - News) today announced the Company has filed a supplemental new drug application (sNDA) with the U.S. Food and Drug Administration (FDA) for VELCADE in the treatment of relapsed or refractory mantle cell lymphoma (MCL), an aggressive subtype of non-Hodgkin's lymphoma (NHL) that is not curable. The filing is based on final data from the Phase II PINNACLE 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.

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