Lenalidomide
Lenalidomide was first approved by the U.S. Food and Drug Administration (FDA) on Dec 27, 2005, then approved by European Medicine Agency (EMA) on June 14, 2007, and approved by Pharmaceuticals and Medical Devices Agency of Japan (PMDA) on June 25, 2010. It was developed and marketed as Revlimid® by Celgene.
Lenalidomide is an analogue of thalidomide with immunomodulatory, antiangiogenic, and antineoplastic properties. In multiple myeloma cells, the combination of lenalidomide and dexamethasone synergizes the inhibition of cell proliferation and the induction of apoptosis. Revlimid® is indicated for the treatment of multiple myeloma (MM), in combination with dexamethasone, in patients who have received at least one prior therapy, 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 and mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
Revlimid® is available as capsule for oral use, containing 2.5, 5, 10, 15, 20 or 25 mg of free Lenalidomide. The recommended dose is 25 mg once daily for multiple myeloma (MM), in combination with 40 mg dexamethasone once daily, 10 mg once daily for myelodysplastic syndromes (MDS) and 25 mg once daily for mantle cell lymphoma (MCL).
Update Date：2016-03-14
- Drug Name：
- Lenalidomide
- Research Code：
- CDC-501; CC-5013
- Trade Name：
- Revlimid®
- MOA：
- Angiogenesis inhibitor
- Indication：
- Myelodysplastic syndrome (MDS); Mantle cell lymphoma (MCL); Multiple myeloma (MM)
- Status：
- Approved
- Company：
- Celgene (Originator)
- Sales：
-
$5,801.1 Million (Y2015);
$4,980 Million (Y2014);;
$4280 Million (Y2013);;
$3766.6 Million (Y2012);;
$3208.2 Million (Y2011); - ATC Code：
- L04AX04
Update Date：2015-07-29
| Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
|---|---|---|---|---|---|---|---|
| 2005-12-27 | Marketing approval | Revlimid | Multiple myeloma (MM),Myelodysplastic syndrome (MDS),Mantle cell lymphoma (MCL) | Capsule | 2.5 mg/5 mg/10 mg/15 mg/20 mg/25 mg | Celgene | Priority; Orphan |
| Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
|---|---|---|---|---|---|---|---|
| 2007-06-14 | Marketing approval | Revlimid | Multiple myeloma (MM),Myelodysplastic syndrome (MDS) | Capsule | 2.5 mg/5 mg/7.5 mg/10 mg/15 mg/20 mg/25 mg | Celgene | Orphan |
| Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
|---|---|---|---|---|---|---|---|
| 2010-08-20 | New indication | Revlimid | Myelodysplastic syndrome (MDS) | Capsule | 5 mg | Celgene | |
| 2010-06-25 | Marketing approval | Revlimid | Multiple myeloma (MM) | Capsule | 5 mg | Celgene |
| Approval Date | Approval Type | Trade Name | Indication | Dosage Form | Strength | Company | Review Classification |
|---|---|---|---|---|---|---|---|
| 2013-01-23 | Marketing approval | 瑞复美/Revlimid | Multiple myeloma (MM) | Capsule | 5 mg | Celgene | |
| 2013-01-23 | Marketing approval | 瑞复美/Revlimid | Multiple myeloma (MM) | Capsule | 10 mg | Celgene | |
| 2013-01-23 | Marketing approval | 瑞复美/Revlimid | Multiple myeloma (MM) | Capsule | 15 mg | Celgene | |
| 2013-01-23 | Marketing approval | 瑞复美/Revlimid | Multiple myeloma (MM) | Capsule | 25 mg | Celgene |
Update Date：2015-08-27
|
Molecular Weight | 259.26 | ||||||||||||
| Formula | C13H13N3O3 | |||||||||||||
| CAS No. | 191732-72-6 (Lenalidomide); | |||||||||||||
| Chemical Name | 3(4-amino-1-oxo 1,3-dihydro-2H-isoindol-2-yl) piperidine-2,6-dione | |||||||||||||
| Lenalidomide （Free Acid/Base）Parameters： | ||||||||||||||
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| *：Calculated by ACD/Labs software V11.02. | ||||||||||||||
Update Date：2016-02-03
Update Date：2015-10-09
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