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
- 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
|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|
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