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FDA Approves Lenalidomide (Revlimid) for Mantle Cell Lymphoma

Drug treats relapsed or progressive disease after prior therapies (June 5)

The FDA has approved lenalidomide (Revlimid; Celgene Corporation) 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.

The approval was based on the results of a phase II, single-arm, open-label study that evaluated 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 patients were required to have documented refractory disease (defined as without a partial response or better during treatment with bortezomib or a bortezomib-containing regimen), or relapsed disease (defined as progression within 1 year after treatment with bortezomib or a bortezomib-containing regimen).

Patients with a creatinine clearance greater than or equal to 60 mL/min were given lenalidomide 25 mg once daily for 21 days every 28 days. Patients with a creatinine clearance greater than or equal to 30 mL/min and less than 60 mL/min were given lenalidomide 10 mg once daily for 21 days every 28 days.

The overall response rate — the study’s primary endpoint — was 26% (34/133), with a complete response rate of 7% (9/133). The median duration of response was 16.6 months.

Revlimid (lenalidomide), an analogue of thalidomide, is contraindicated in pregnancy, and if used during pregnancy may cause birth defects or embryo-fetal death. It is available only through a restricted distribution program.

Source: Celgene; June 5, 2013.

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