Celgene Corporation has announced that the 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 lenalidomide in 134 patients with MCL who had received prior treatment with rituximab, cyclophosphamide, an anthracycline (or mitoxantrone), and bortezomib alone or in combination. Patients were required to have documented refractory disease (defined as without any response of partial response or better during treatment with bortezomib or a bortezomib-containing regimen), or relapsed disease (defined as progression within one year after treatment with bortezomib or a bortezomib-containing regimen). Patients with a creatinine clearance ≥60mL/min were given lenalidomide at 25mg once daily for 21 days every 28 days. Patients with a creatinine clearance ≥30mL/min and <60mL/min were given lenalidomide at a dose of 10mg once daily for 21 days every 28 days.