Difference between revisions of "Alemtuzumab (Campath)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
*2001-05-07: Initial accelerated approval for the treatment of patients with [[Chronic lymphocytic leukemia | B-cell chronic lymphocytic leukemia]] who have been treated with [[Regimen_classes#Alkylator-based_regimen|alkylating agents]] and who have failed [[Regimen_classes#Fludarabine-based_regimen| fludarabine therapy]].<ref>[http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/alemmil050701L.htm FDA approval letter dated May 7th, 2001]</ref> ''(Based on Keating et al. 2002, Rai et al. 2002, and Lozanski et al. 2004)'' | *2001-05-07: Initial accelerated approval for the treatment of patients with [[Chronic lymphocytic leukemia | B-cell chronic lymphocytic leukemia]] who have been treated with [[Regimen_classes#Alkylator-based_regimen|alkylating agents]] and who have failed [[Regimen_classes#Fludarabine-based_regimen| fludarabine therapy]].<ref>[http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/alemmil050701L.htm FDA approval letter dated May 7th, 2001]</ref> ''(Based on Keating et al. 2002, Rai et al. 2002, and Lozanski et al. 2004)'' | ||
| − | *2007-09-19: Converted to regular approval and indication expanded to include use as a single agent for treatment of [[Chronic lymphocytic leukemia | B-cell chronic lymphocytic leukemia (B-CLL)]] ''(Based on CAM 307)'' | + | **2007-09-19: Converted to regular approval and indication expanded to include use as a single agent for treatment of [[Chronic lymphocytic leukemia | B-cell chronic lymphocytic leukemia (B-CLL)]] ''(Based on CAM 307)'' |
*2012-10: Genzyme withdraws drug from USA and EU (still available for B-CLL patients, however). See Lancet editorial.<ref>[https://doi.org/10.1016/S0140-6736(12)61776-0 Alemtuzumab for multiple sclerosis]</ref> | *2012-10: Genzyme withdraws drug from USA and EU (still available for B-CLL patients, however). See Lancet editorial.<ref>[https://doi.org/10.1016/S0140-6736(12)61776-0 Alemtuzumab for multiple sclerosis]</ref> | ||
| + | |||
==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
*2001-07-06: Initial authorization for the treatment of patients with B-cell chronic lymphocytic leukaemia (B-CLL) for whom fludarabine combination chemotherapy is not appropriate. | *2001-07-06: Initial authorization for the treatment of patients with B-cell chronic lymphocytic leukaemia (B-CLL) for whom fludarabine combination chemotherapy is not appropriate. | ||
Revision as of 02:12, 20 April 2023
General information
Class/mechanism: Anti-CD52 antibody that is believed to cause antibody-dependent cell-mediated cytotoxicity of cells that express the CD52 antigen on their surface: B and T lymphocytes, most monocytes, macrophages, natural killer (NK) cells, and a subpopulation of granulocytes.[1][2][3]
Route: IV
Extravasation: neutral
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, Medscape, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
Toxicity management
- Use of alemtuzumab (Lemtrada) requires participation in the Lemtrada REMS program.
Diseases for which it is used
- Adult T-cell leukemia-lymphoma
- Autoimmune cytopenia
- Chronic lymphocytic leukemia
- Cutaneous T-cell lymphoma
- Hypereosinophilic syndrome
- Myelodysplastic syndrome
- Peripheral T-cell lymphoma
- T-cell prolymphocytic leukemia
- Waldenström macroglobulinemia
Patient drug information
- Alemtuzumab (Campath) patient drug information (Chemocare)[4]
- Brief patient counseling information can be found at the end of page 2 of the Alemtuzumab (Campath) package insert
- Alemtuzumab (Campath) patient drug information (UpToDate)[5]
History of changes in FDA indication
- 2001-05-07: Initial accelerated approval for the treatment of patients with B-cell chronic lymphocytic leukemia who have been treated with alkylating agents and who have failed fludarabine therapy.[6] (Based on Keating et al. 2002, Rai et al. 2002, and Lozanski et al. 2004)
- 2007-09-19: Converted to regular approval and indication expanded to include use as a single agent for treatment of B-cell chronic lymphocytic leukemia (B-CLL) (Based on CAM 307)
- 2012-10: Genzyme withdraws drug from USA and EU (still available for B-CLL patients, however). See Lancet editorial.[7]
History of changes in EMA indication
- 2001-07-06: Initial authorization for the treatment of patients with B-cell chronic lymphocytic leukaemia (B-CLL) for whom fludarabine combination chemotherapy is not appropriate.
- 2012-08-08: Authorization withdrawn at the request of the manufacturer, for commercial reasons
Also known as
- Code name: LDP03
- Brand names: Campath, Campath-1H, Lemtrada, MabCampath
References
- ↑ 1.0 1.1 Alemtuzumab (Campath) package insert
- ↑ Alemtuzumab (Campath) package insert (locally hosted backup)
- ↑ Campath manufacturer's website
- ↑ Alemtuzumab (Campath) patient drug information (Chemocare)
- ↑ Alemtuzumab (Campath) patient drug information (UpToDate)
- ↑ FDA approval letter dated May 7th, 2001
- ↑ Alemtuzumab for multiple sclerosis
Categories:
- Drugs
- Intravenous medications
- Neutral
- Anti-CD52 antibodies
- Adult T-cell leukemia-lymphoma medications
- Autoimmune cytopenia medications
- Chronic lymphocytic leukemia medications
- Cutaneous T-cell lymphoma medications
- Hypereosinophilic syndrome medications
- Myelodysplastic syndrome medications
- Peripheral T-cell lymphoma medications
- T-cell prolymphocytic leukemia medications
- Waldenström macroglobulinemia medications
- REMS program
- FDA approved in 2001
- EMA approved in 2001
- EMA withdrawn in 2012