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FDA Approved for Maintenance: Lenalidomide (Revlimid)

Updated: Nov 6, 2021


On February 22, 2017, the U.S. Food and Drug Administration approved lenalidomide (Revlimid, Celgene Corp.) as maintenance therapy for patients with multiple myeloma following autologous stem cell transplant.


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. In 2015, the indication was expanded for use in combination with dexamethasone for the treatment of 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 current approval was based on two randomized, controlled trials evaluating the efficacy and safety of lenalidomide maintenance therapy for the treatment of multiple myeloma patients after autologous stem cell transplant

CALGB 100104 and IFM 2005-02 trials


Click below for more details.

https://www.fda.gov/drugs/resources-information-approved-drugs/lenalidomide-revlimid

 

NCT00114101: Phase 3 - CALGB 100104 - Lenalidomide in Patients With MM Undergoing Auto Transplant

https://www.themyelomaclinicaltrials.com/single-post/calgb100104



NCT00430365: Phase 3 - Maintenance Therapy Using Lenalidomide in Myeloma (IFM2005-02)

https://www.themyelomaclinicaltrials.com/single-post/ifm2005-02

 

Learn more:

02/2017: FDA Approval

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021880Orig1s049ltr.pdf









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