Millennium's Velcade gets FDA priority review

By Elaine Rigoli

Tampa, Fla., Aug. 9 - The Food and Drug Administration has granted priority review designation to Millennium Pharmaceuticals, Inc.'s supplemental New Drug Application for Velcade for the treatment of relapsed mantle cell lymphoma, an aggressive, incurable subtype of non-Hodgkin's lymphoma (NHL) for which there is no current standard of care.

"Receiving priority review is a significant step forward in accelerating and expanding the potential of Velcade in cancers beyond multiple myeloma. Our mantle cell lymphoma application, for which we can expect a decision from the FDA by Dec. 9, 2006, is the first step in an advanced NHL development program exploring the use of Velcade in this large and growing patient population in need of new treatment options," president and chief executive officer Deborah Dunsire said in a news release.

The supplemental NDA submission was based on final phase 2 data from the Pinnacle study, which showed a 33% overall response rate and an 8% complete response rate.

Importantly, the median duration of response was 9.2 months, and 13.5 months in patients who achieved a complete response, the release said.

Millennium is a biopharmaceutical company based in Cambridge, Mass.

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