Revlimid FDA Approval History
Last updated by Judith Stewart, BPharm on Sep 7, 2020.
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 timeline for Revlimid
Date | Article |
---|
May 28, 2019 | Approval 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, 2017 | Approval 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, 2015 | Approval FDA Expands Indication for Revlimid (lenalidomide) in Combination with Dexamethasone to Include Patients Newly Diagnosed with Multiple Myeloma |
Jun 5, 2013 | Approval FDA Approves Revlimid (lenalidomide) for the Treatment of Patients with Relapsed or Refractory Mantle Cell Lymphoma |
Jun 29, 2006 | Approval Revlimid in Combination With Dexamethasone sNDA Granted Approval By FDA for Treatment of Multiple Myeloma |
Dec 28, 2005 | Approval FDA Grants Revlimid NDA Approval |
Oct 3, 2005 | Revlimid PDUFA Date Extended Three Months By FDA |
Sep 14, 2005 | FDA Oncologic Drugs Advisory Committee Recommends Revlimid for Full Approval |
Sep 13, 2005 | FDA and Celgene Revlimid Briefing Documents for Advisory Committee Meeting Available Online |
Jun 21, 2005 | FDA Grants Priority Review for Revlimid NDA for Treatment of Low- and Intermediate- Risk MDS With Deletion 5q Chromosomal Abnormality |
Jun 7, 2005 | Revlimid (lenalidomide) New Drug Application Accepted for Review by FDA |
Apr 8, 2005 | Revlimid New Drug Application Submitted to FDA for Review |
Further information
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