The Food and Drug Administration (FDA) has expanded the indication for Revlimid (lenalidomide; Celgene) to include use as a maintenance therapy in patients with multiple myeloma following autologous hematopoietic stem cell transplant (auto-HSCT).

The approval was based on two randomized, controlled trials that included over 1,000 patients comparing lenalidomide maintenance therapy given until disease progression or unacceptable toxicity after auto-HSCT versus no maintenance. In both studies, the primary efficacy endpoint was progression-free survival (PFS).

Study 1 (CALGB 100104) showed a median PFS of 5.7 years (95% CI: 4.4-not estimable) compared to 1.9 years (95% CI: 1.6-2.5) for no maintenance, a difference of 3.8 years (HR 0.38 [95% CI: 0.28-0.50]). Median overall survival was 9.3 years (95% CI: 8.5-not estimable) for patients who received lenalidomide vs. 7 years (95% CI: 5.9-8.6) for no maintenance (HR 0.59 [95% CI: 0.44-0.78]).

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Study 2 (IFM 2005-02) showed a median PFS of 3.9 years (95% CI: 3.3-4.7) compared to 2 years (95% CI: 1.8-2.3) for no maintenance, a difference of 1.9 years (HR 0.53 [95% CI: 0.44-0.64]). Median overall survival was 8.8 years (95% CI: 7.4-not estimable) for patients treated with lenalidomide vs. 7.3 years (95% CI: 6.7-9.0) for no maintenance (HR 0.90 [95% CI: 0.72-1.13]).

Adverse events seen in these trials were similar to those previously described in the lenalidomide product labeling. Neutropenia was the most frequently reported grade 3/4 adverse event (56%). Compared with placebo, an increased incidence of second primary malignancies was reported among patients treated with lenalidomide. The potential benefits of therapy and the risk of second primary malignancies should be take into account when considering treatment with lenalidomide.

In 2006, lenalidomide, an orally administered thalidomide analogue, received FDA approval for use with dexamethasone in patients with multiple myeloma who received at least one prior therapy. The indication was expanded in 2015 to include patients newly diagnosed with multiple myeloma. Lenalidomide is also approved in myelodysplastic syndromes and mantle cell lymphoma.

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