The FDA approved lenalidomide capsules (Revlimid; Celgene Corporation) for the treatment of patients with mantle-cell lymphoma whose disease has relapsed or progressed after 2 previous therapies, one of which included bortezomib (Velcade). Lenalidomide is already approved for multiple myeloma (as is bortezomib).
The FDA approved the new indication for lenalidomide based a single-arm, multicenter clinical trial of 134 patients (median age, 67 years) with mantle-cell lymphoma. All of the patients previously received treatment with bortezomib, and 60% of the 134 patients had disease that was refractory to bortezomib therapy. Overall, the patients received a median of 4 previous therapies for mantle-cell lymphoma; 61% of the patients had mantle-cell lymphoma for at least 3 years.
The efficacy end points were overall response rate (ORR) and duration of response. The ORR was defined as the proportion of patients whose best response was complete response (CR), CR unconfirmed, or partial response (PR). The ORR was 26% (95% confidence interval [CI], 18.4-33.9) among the 133 evaluable patients, CR or CR unconfirmed was achieved by 9 (7%) patients, and 25 (19%) patients achieved a PR. The median duration of response of the patients who achieved any response was 16.6 months (95% CI, 7.7-26.7).
The median duration of therapy was 95 days, and 58% of the patients received ≥3 cycles of therapy. Overall, 19% of the patients discontinued treatment because of adverse events.
The most common (≥5%) grade 3 to 4 adverse reactions were neutropenia, thrombocytopenia, anemia, pneumonia, leukopenia, fatigue, febrile neutropenia, dyspnea, and diarrhea.
The recommended oral dose and schedule for lenalidomide is 25 mg once daily on day 1 through day 21 of a 28-day cycle. Lenalidomide should be taken at approximately the same time daily, with no regard to food. In addition, as part of this new supplemental indication, the FDA also approved a new 20-mg capsule strength of lenalidomide. (June 5, 2013)
