CAMBRIDGE, Mass., Aug. 9 (UPI) -- Millennium said Wednesday the U.S. Food and Drug Administration granted priority review to Velcade for relapsed mantle cell lymphoma.
Velcade is currently approved for the treatment of multiple-myeloma patients who have received at least one prior therapy. Millennium's supplemental new drug application seeks to expand the drug's indications to include relapsed mantle cell lymphoma, an incurable subtype of non-Hodgkin's lymphoma.
"Receiving priority review is a significant step forward in accelerating and expanding the potential of Velcade in cancers beyond multiple myeloma," said Deborah Dunsire, Millennium's president and chief executive officer.
"Our mantle cell lymphoma application, for which we can expect a decision from the FDA by December 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," Dunsire added.
Millennium's filing was based on the phase 2 PINNACLE study, which showed a 33 percent overall response rate and an 8 percent complete response rate lasting for a median duration of 13.5 months.
