FDA Approved for NDMM: Lenalidomide (Revlimid)

SUMMIT, N.J., February 18, 2015 --(BUSINESS WIRE)-- Celgene Corporation (NASDAQ:CELG) today announced that the U.S. Food and Drug Administration (FDA) has expanded the existing indication for Revlimid (lenalidomide) in combination with dexamethasone to include patients newly diagnosed with multiple myeloma (NDMM). Revlimid plus dexamethasone was previously approved in June 2006 for use in multiple myeloma patients who have received at least one prior therapy.

Two identically designed, multicenter, double-blind, phase III clinical trials MM-009 and MM-010 were conducted in Europe and the United States to assess the effect of lenalidomide in combination with dexamethasone versus dexamethasone plus placebo.

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MM-009: NCT00056160 : Phase 3 - CC-5013 Plus Dex Versus Dex Alone in Previously Treated Subjects With Multiple Myeloma

https://www.themyelomaclinicaltrials.com/single-post/revlimid-approval-mm-009

MM-010: NCT00424047: A Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma

https://www.themyelomaclinicaltrials.com/single-post/revlimid-approval-mm-010

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Learn more:

02/2015: FDA Approval

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021880Orig1s041ltr.pdf

https://www.drugs.com/newdrugs/fda-expands-indication-revlimid-lenalidomide-combination-dexamethasone-include-patients-newly-4167.html