Millennium gets priority review at FDA for Velcade
Cambridge biopharmaceutical company Millennium Pharmaceuticals Inc. said today that the Food and Drug Administration granted priority review for the injection Velcade in patients with newly diagnosed blood cancer multiple myeloma.
Velcade is approved in the United States for the treatment of patients with multiple myeloma or mantle cell lymphoma who already have received at least one prior therapy.
Multiple myeloma is the second most common blood cancer, according to Millennium. Mantle cell lymphoma is a rare type of cancer whose cause is unknown.
Millennium is seeking an additional approval for Velcade as an initial treatment for multiple myeloma. The priority review status puts the drug on track for potential approval in mid-2008.
Priority review is granted by the FDA for a treatment that addresses an unmet medical need and shows an improvement over existing therapies. The FDA expedites the approval process for applications granted priority review from 10 to six months.
Velcade is being codeveloped by Millennium and Johnson & Johnson Pharmaceutical Research & Development L.L.C.
"Priority review designation puts us on track for a potential label expansion decision by June 20," said Chief Medical Officer Dr. Nancy Simonian. "The rapid action by the FDA puts us one step closer to establishing Velcade based therapies as a standard of care for patients with newly diagnosed multiple myeloma." (AP)