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# FDA Approves Expanded Use for Celgene’s Revlimid
- URL: https://www.fdaweb.com/fda-approves-expanded-use-for-celgenes-revlimid/
- Published: 2017-02-23T12:00:00.000Z
- Updated: 2026-09-14T22:08:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138052

FDA has approved an expanded indication for Celgene’s Revlimid (lenalidomide) as maintenance therapy for patients with multiple myeloma following autologous stem cell transplant. The orally administered thalidomide analogue was originally approved in 2006 for use with dexamethasone in patients with multiple myeloma who received at least one prior therapy. In 2015, the indication was expanded for use in combination with dexamethasone for treating patients with multiple myeloma, to include newly diagnosed multiple myeloma patients who are not eligible for autologous stem cell transplant. Lenalidomide is also approved in myelodysplastic syndromes and mantle cell lymphoma.

The latest approval was based on data from two randomized, controlled trials (CALGB 100104 and IFM 2005-02). The trials showed about a 15-month (CALGB) and 18-month (IFM) progression-free survival advantage for patients treated with lenalidomide compared with those on placebo. “The median overall survival was 111 and 106 months for patients treated with lenalidomide compared with 84 and 88 months for patients receiving placebo in the CALGB and IFM trials, respectively,” an FDA release says.