FDA GRANTS MILLENNIUM'S LYMPHOMA DRUG PRIORITY REVIEW

The FDA is granting Millennium Pharmaceuticals priority review for Velcade, a drug used to treat relapsed mantle cell lymphoma (MCL), the company said.

The FDA grants priority review to a product that meets an unmet medical need and would be a significant improvement in treatment compared to existing therapies. The agency's decision ensures an accelerated review of the company's supplemental new drug application, with the FDA targeting a decision within six months, the company said. Millennium is expecting a decision by Dec. 9.

MCL is an incurable subtype of non-Hodgkin's lymphoma for which there is no current standard of care. Non-Hodgkin's lymphoma is the most common hematological cancer, the fifth leading cause of cancer death and the second fastest growing form of cancer in the U.S.

"Receiving priority review is a significant step forward in accelerating and expanding the potential of Velcade in cancers beyond multiple myeloma," Deborah Dunsire, president and CEO of Millennium, said.