FDA Approves Revlimid for Mantle Cell Lymphoma

On June 5, the U.S. Food and Drug Administration notified Celgene corporation that the agency has approved the company’s supplemental new drug application (sNDA) for Revlimid (lenalidomide) in the treatment of patients diagnosed with mantle cell lymphoma (MCL) whose disease has relapsed or progressed following two prior therapies, one of which included bortezomib.

Andre Goy, MD, MS, 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, said:

There remains a tremendous unmet need for patients with previously-treated mantle cell lymphoma. The approval of lenalidomide delivers a new option and the first oral therapy in this area of lymphoma.

The FDA approval was based on results from the MCL-001 phase II, multi-center, single-arm, open-label trial of lenalidomide in 134 patients with mantle cell lymphoma who had been given prior treatment with rituximab, cyclophosphamide, an anthracycline (or mitoxantrone), and bortezomib alone or in combination. Documented refractory or relapsed disease was a requirement.

You can read the FDA's supplemental NDA approval letter here.

Source: Celgene