US FDA grants Celgene's Revlimid lymphoma approval

The US FDA has approved Celgene Corporation's supplemental new drug application 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.

Revlimid is already approved to treat multiple myeloma and the blood disorder myelodysplastic syndromes. In its first quarter, Revlimid's sales totalled approximately US $1 billion.

"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."

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.

Despite the unmet need, analysts predict only a slight revenue boost for Celgene from Revlimid and its new indication.

The FDA approval was based on a phase 2 clinical trial 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. The primary endpoint - overall response rate based on a review of radiographic scans by an independent review committee according to a modified version of the International Workshop Lymphoma Response Criteria – was 26% with a complete response rate of 7%. The median duration of response was 16.6 months.