FDA Approved for RRMM: Lenalidomide (Revlimid)

SUMMIT, N.J., June 29, 2006 /PRNewswire/ -- Celgene Corporation (Nasdaq: CELG) announced that the U.S. Food and Drug Administration (FDA) has granted approval for its Supplemental New Drug Application (sNDA) for an additional indication for Revlimid (lenalidomide), for use in combination with dexamethasone as a treatment for patients with multiple myeloma 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:

06/29/2006: FDA Approval

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021880s001LTR.pdf

https://www.drugs.com/newdrugs/revlimid-combination-dexamethasone-snda-granted-approval-fda-multiple-myeloma-4985.html