Difference between revisions of "Lenalidomide (Revlimid)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
===[[Follicular lymphoma]]; [[Marginal zone lymphoma]]=== | ===[[Follicular lymphoma]]; [[Marginal zone lymphoma]]=== | ||
| − | * | + | *2019-05-28: Approved in combination with a rituximab product for previously treated [[Follicular lymphoma|follicular lymphoma (FL)]] and previously treated [[marginal zone lymphoma|marginal zone lymphoma (MZL)]]. ''(New disease entity; based on AUGMENT and MAGNIFY)'' |
===[[Mantle cell lymphoma]]=== | ===[[Mantle cell lymphoma]]=== | ||
| − | * | + | *2013-06-05: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm355438.htm Approved] for patients with [[Mantle cell lymphoma |mantle cell lymphoma (MCL)]] whose disease has relapsed or progressed after two prior therapies, one of which included [[Bortezomib (Velcade) | bortezomib]].<ref name="insert"></ref> ''(New disease entity; based on EMERGE)'' |
===[[Multiple myeloma]]=== | ===[[Multiple myeloma]]=== | ||
| − | * | + | *2006-06-29: [http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm095626.htm Approved] for treatment of patients with [[Multiple myeloma |multiple myeloma (MM)]], in combination with [[Dexamethasone (Decadron) | dexamethasone]], in patients who have received at least one prior therapy.] ''(New disease entity; based on MM-009 and MM-010)'' |
| − | * | + | *2015-02-17: Approved for [[Multiple myeloma |multiple myeloma (MM)]], in combination with dexamethasone. ''(Prior treatment requirement removed; based on FIRST<sub>MM</sub>)'' |
| − | * | + | *2017-02-22: [https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm542791.htm Approval expanded] as maintenance therapy for patients with [[multiple myeloma]] following autologous stem cell transplant. ''(Approval expanded to maintenance therapy after upfront treatment; based on CALGB 100104 and IFM 2005-02)'' |
===[[Myelodysplastic syndrome]]=== | ===[[Myelodysplastic syndrome]]=== | ||
| − | *12 | + | *2005-12-28: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2005/ucm108546.htm Approved] for patients with transfusion-dependent anemia due to low- or intermediate-1-risk [[Myelodysplastic syndrome | myelodysplastic syndromes (MDS)]] associated with a [[Biomarkers#Deletion|deletion]] [[Biomarkers#5q|5q]] abnormality with or without additional cytogenetic abnormalities.<ref name="insert"></ref> ''(Initial approval; based on CC-5013-MDS-003)'' |
==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
| − | * | + | *2007-06-14: Initial authorization |
| + | ==History of changes in Health Canada indication== | ||
| + | *2008-01-17: Initial notice of compliance with conditions | ||
| + | *2013-06-06: Conditions were met | ||
| + | |||
==Also known as== | ==Also known as== | ||
*'''Code names:''' CC-5013, IMiD-1, NSC-703813 | *'''Code names:''' CC-5013, IMiD-1, NSC-703813 | ||
| Line 101: | Line 105: | ||
[[Category:FDA approved in 2005]] | [[Category:FDA approved in 2005]] | ||
[[Category:EMA approved in 2007]] | [[Category:EMA approved in 2007]] | ||
| + | [[Category:Health Canada approved in 2008]] | ||
[[Category:WHO Essential Cancer Medicine]] | [[Category:WHO Essential Cancer Medicine]] | ||
Revision as of 01:45, 31 March 2023
General information
Class/mechanism: Second-generation immunomodulatory drug (IMiD) similar to Thalidomide (Thalomid); mechanism not fully understood. Lenalidomide's mechanism may involve immunomodulatory, antiinflammatory, and antiangiogenic effects and suppression of tumor necrosis factor-alpha (TNF-α) from peripheral blood mononuclear cells. It has been observed to inhibit cells with the 5q deletion in myelodysplastic syndromes. It has also been seen in vitro to inhibit cyclooxygenase-2 (COX-2) expression, but not COX-1.[1][2][3][4]
Route: PO
Extravasation: n/a
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
Toxicity management
- Use of Lenalidomide (Revlimid) requires participation the Revlimid REMS program.[4]
Thrombosis
- 2006 (two simultaneously published NEJM letters to the editor): link to original article PubMed link to letter #1 PubMed link to letter #2
- 2011: Larocca A, Cavallo F, Bringhen S, Di Raimondo F, Falanga A, Evangelista A, Cavalli M, Stanevsky A, Corradini P, Pezzatti S, Patriarca F, Cavo M, Peccatori J, Catalano L, Carella AM, Cafro AM, Siniscalchi A, Crippa C, Petrucci MT, Yehuda DB, Beggiato E, Di Toritto TC, Boccadoro M, Nagler A, Palumbo A. Aspirin or enoxaparin thromboprophylaxis for patients with newly diagnosed multiple myeloma treated with lenalidomide. Blood. 2012 Jan 26;119(4):933-9. Epub 2011 Aug 11. link to original article PubMed
Diseases for which it is established (work in progress)
- Multiple myeloma
- Myelodysplastic syndrome
- Non-Hodgkin lymphoma
Diseases for which it is used
- Adult T-cell leukemia-lymphoma
- B-cell lymphoma of mucosa-associated lymphoid tissue
- Chronic lymphocytic leukemia
- Chronic myelomonocytic leukemia
- Cutaneous T-cell lymphoma
- Diffuse large B-cell lymphoma
- Hodgkin lymphoma
- Light-chain (AL) amyloidosis
- Myelofibrosis
- Peripheral T-cell lymphoma
- Plasma cell leukemia
- POEMS syndrome
- Polycythemia vera
- Smoldering multiple myeloma
- Transformed lymphoma
- Waldenström macroglobulinemia
Patient drug information
- Lenalidomide (Revlimid) package insert[1]
- Lenalidomide (Revlimid) patient medication guide[5]
- Lenalidomide (Revlimid) patient drug information (Chemocare)[6]
- Lenalidomide (Revlimid) patient drug information (UpToDate)[7]
History of changes in FDA indication
Follicular lymphoma; Marginal zone lymphoma
- 2019-05-28: Approved in combination with a rituximab product for previously treated follicular lymphoma (FL) and previously treated marginal zone lymphoma (MZL). (New disease entity; based on AUGMENT and MAGNIFY)
Mantle cell lymphoma
- 2013-06-05: Approved for patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.[1] (New disease entity; based on EMERGE)
Multiple myeloma
- 2006-06-29: Approved for treatment of patients with multiple myeloma (MM), in combination with dexamethasone, in patients who have received at least one prior therapy.] (New disease entity; based on MM-009 and MM-010)
- 2015-02-17: Approved for multiple myeloma (MM), in combination with dexamethasone. (Prior treatment requirement removed; based on FIRSTMM)
- 2017-02-22: Approval expanded as maintenance therapy for patients with multiple myeloma following autologous stem cell transplant. (Approval expanded to maintenance therapy after upfront treatment; based on CALGB 100104 and IFM 2005-02)
Myelodysplastic syndrome
- 2005-12-28: Approved for patients with 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.[1] (Initial approval; based on CC-5013-MDS-003)
History of changes in EMA indication
- 2007-06-14: Initial authorization
History of changes in Health Canada indication
- 2008-01-17: Initial notice of compliance with conditions
- 2013-06-06: Conditions were met
Also known as
- Code names: CC-5013, IMiD-1, NSC-703813
- Brand names: Adlinod, Immunomide, Kabillon, Lenalid, Lenalidomid, Lenangio, Lenmid, Lenome, Lenomust, Lenzest, Lidmed, Linamide, Lynide, MyeloSar, Revlimid
References
- ↑ 1.0 1.1 1.2 1.3 1.4 Lenalidomide (Revlimid) package insert
- ↑ Lenalidomide (Revlimid) package insert (locally hosted backup)
- ↑ Revlimid manufacturer's site
- ↑ 4.0 4.1 Revlimid REMS program
- ↑ Lenalidomide (Revlimid) patient medication guide
- ↑ Lenalidomide (Revlimid) patient drug information (Chemocare)
- ↑ Lenalidomide (Revlimid) patient drug information (UpToDate)
Categories:
- Drugs
- Oral medications
- Mutation-specific medications
- Immunomodulatory drugs (IMiDs)
- Adult T-cell leukemia-lymphoma medications
- Chronic lymphocytic leukemia medications
- Chronic myelomonocytic leukemia medications
- Cutaneous T-cell lymphoma medications
- Diffuse large B-cell lymphoma medications
- Follicular lymphoma medications
- Hodgkin lymphoma medications
- Light-chain (AL) amyloidosis medications
- MALT lymphoma medications
- Mantle cell lymphoma medications
- Marginal zone lymphoma medications
- Multiple myeloma medications
- Myelodysplastic syndrome medications
- Myelofibrosis medications
- Peripheral T-cell lymphoma medications
- Plasma cell leukemia medications
- POEMS syndrome medications
- Polycythemia vera medications
- Smoldering multiple myeloma medications
- Transformed lymphoma medications
- Waldenström macroglobulinemia medications
- REMS program
- FDA approved in 2005
- EMA approved in 2007
- Health Canada approved in 2008
- WHO Essential Cancer Medicine