FDA Approves Lenalidomide for Relapsed/Refractory Mantle Cell Lymphoma

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The U.S. Food and Drug Administration has approved lenalidomide (Revlimid) for the treatment of patients with mantle cell lymphoma whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib (Velcade).

Clinical Trial

The approval was based on the results of a phase II, single-arm, multicenter clinical trial enrolling 134 patients with mantle cell lymphoma who have relapsed after or were refractory to bortezomib or a bortezomib-containing regimen. All patients received prior treatment with bortezomib, and 60% were documented to have disease refractory to bortezomib therapy. Patients received a median of four prior therapies for mantle cell lymphoma. The median age was 67 years, 81% were male, 96% were Caucasian, and 61% had mantle cell lymphoma for at least 3 years.

The primary endpoints of the study were overall response rate and duration of response. In the 133 patients who were evaluable for efficacy, the overall response rate was 26% (95% confidence interval [CI] = 18.4–33.9). Complete response or complete response unconfirmed was achieved by 9 patients (7%), and 25 patients (19%) achieved a partial response.

The median duration of response for the 34 patients who achieved a complete response, complete response unconfirmed, or partial response was 16.6 months (95% CI = 7.7–26.7).

Adverse Effects

Safety data were evaluated in 134 patients who received at least one dose of lenalidomide. The median duration of therapy was 95 days (range, 1–1,002), and 78 patients (58%) received three or more cycles of therapy. Seventy-six patients (57%) underwent at least one dose interruption due to adverse events, and 51 patients (38%) underwent at least one dose reduction due to adverse events. Twenty-six patients (19%) discontinued treatment due to adverse events. ■




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