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Revlimid Approval History

FDA Approved: Yes (First approved December 27, 2005)
Brand name: Revlimid
Generic name: lenalidomide
Dosage form: Capsules
Company: Celgene Corporation
Treatment for: Myelodysplastic Syndrome, Multiple Myeloma, Lymphoma, Follicular Lymphoma

Revlimid (lenalidomide) is a thalidomide analogue indicated for the treatment of adult patients with:

  • Multiple myeloma (MM), in combination with dexamethasone.
  • MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT).
  • Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities.
  • Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
  • Previously treated follicular lymphoma (FL), in combination with a rituximab product.
  • Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product.

Development History and FDA Approval Process for Revlimid

DateArticle
May 28, 2019Approval FDA Approves Revlimid (lenalidomide) In Combination with Rituximab for the Treatment of Adult Patients with Previously Treated Follicular Lymphoma or Marginal Zone Lymphoma
Feb 22, 2017Approval FDA Expands Indication for Revlimid (lenalidomide) as a Maintenance Treatment for Patients with Multiple Myeloma Following Autologous Hematopoietic Stem Cell Transplant (auto-HSCT)
Feb 18, 2015Approval FDA Expands Indication for Revlimid (lenalidomide) in Combination with Dexamethasone to Include Patients Newly Diagnosed with Multiple Myeloma
Jun  5, 2013Approval FDA Approves Revlimid (lenalidomide) for the Treatment of Patients with Relapsed or Refractory Mantle Cell Lymphoma
Jun 29, 2006Approval Revlimid in Combination With Dexamethasone sNDA Granted Approval By FDA for Treatment of Multiple Myeloma
Dec 28, 2005Approval FDA Grants Revlimid NDA Approval
Oct  3, 2005Revlimid PDUFA Date Extended Three Months By FDA
Sep 14, 2005FDA Oncologic Drugs Advisory Committee Recommends Revlimid for Full Approval
Sep 13, 2005FDA and Celgene Revlimid Briefing Documents for Advisory Committee Meeting Available Online
Jun 21, 2005FDA Grants Priority Review for Revlimid NDA for Treatment of Low- and Intermediate- Risk MDS With Deletion 5q Chromosomal Abnormality
Jun  7, 2005Revlimid (lenalidomide) New Drug Application Accepted for Review by FDA
Apr  8, 2005Revlimid New Drug Application Submitted to FDA for Review

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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