SUMMIT, N.J. - Sunday, June 9th 2013 [BUSINESS WIRE/ ME NewsWire]
-- Celgene Corporation (NASDAQ: CELG) today announced the U.S. Food and Drug Administration (FDA) has approved the company’s supplemental new drug application (sNDA) for REVLIMID® (lenalidomide) for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
"There remains a tremendous unmet need for patients with previously-treated mantle cell lymphoma,” said Andre Goy, M.D., M.S., Chairman and Director and Chief of Lymphoma, John Theurer Cancer Center at Hackensack UMC and Chief Science Officer and Director of Research and Innovation at Regional Cancer Care Associates, LLC. "The approval of lenalidomide delivers a new option, and the first oral therapy in this area of lymphoma.”
The approval was based on the results of MCL-001, a phase II, multi-center, single arm, open label study evaluating len
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