The FDA has cleared Celgene's supplemental new drug application (sNDA) for Revlimid (lenalidomide) for the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL).
The approval follows positive data from MCL-001 phase II, multi-center study of lenalidomide, which was conducted in 134 MCL patients previously treated with rituximab, cyclophosphamide, an anthracycline (or mitoxantrone), and bortezomib alone or in combination.
Reviewed by an independent committee as per a modified version of the International Workshop Lymphoma Response Criteria, the study's primary endpoint of overall response rate based on a review of radiographic scans was 26% with a complete response rate of 7%, while the median duration of response was 16.6 months.
Regional Cancer Care Associates research and innovation chief science officer and director and Hackensack UMC John Theurer Cancer Center chairman and director and chief of lymphoma Andre Goy said there is a high 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," Goy added.
Because of embryo-fetal risk, the thalidomide analogue is available through a restricted distribution program referred to as REVLIMID Risk Evaluation and Mitigation Strategy (REMS).
