Difference between revisions of "Talimogene laherparepvec (Imlygic)"
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==General information== | ==General information== | ||
| − | Class/mechanism: | + | Class/mechanism: Genetically modified oncolytic Viral Therapy. Talimogene laherparepvec (Imlygic) is a live, attenuated Herpes Simplex Virus-1 (HSV-1) that has been genetically modified to express human granulocyte-macrophage colony-stimulating factor (huGM-CSF). The modified virus is able to reproduce inside of tumors. The exact mechanism of action is unknown, but the anti-tumor response may be due to the expression of huGM-CSF. It has been observed to cause tumor lysis and release of tumor-derived antigens.<ref name=insert>[http://pi.amgen.com/united_states/imlygic/imlygic_pi.pdf Talimogene laherparepvec (Imlygic) package insert]</ref><ref>[[Media:Talimogenelaherparepvec.pdf | Talimogene laherparepvec (Imlygic) package insert (locally hosted backup)]]</ref><ref>[http://imlygic.com/ Imlygic manufacturer's website]</ref><ref>Lawler SE, Chiocca EA. Oncolytic Virus-Mediated Immunotherapy: A Combinatorial Approach for Cancer Treatment. J Clin Oncol. 2015;33(25):2812-4. [http://jco.ascopubs.org/content/33/25/2812.long link to original article] [http://www.ncbi.nlm.nih.gov/pubmed/26215964 PubMed]</ref> |
| − | <br>Route: SC | + | <br>Route: SC |
<br>Extravasation: n/a | <br>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 [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], , [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information. | 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 [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], , [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information. | ||
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| + | ==Diseases for which it is used== | ||
| + | *[[Melanoma]] | ||
==Patient drug information== | ==Patient drug information== | ||
| − | * | + | *[http://pi.amgen.com/united_states/imlygic/imlygic_pi.pdf Talimogene laherparepvec (Imlygic) package insert]<ref name="insert"></ref> |
| + | |||
| + | ==History of changes in FDA indication== | ||
| + | *10/27/2015: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm469571.htm FDA approved] "for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery." | ||
==Also Known As== | ==Also Known As== | ||
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*T-VEC | *T-VEC | ||
*Imlygic | *Imlygic | ||
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==References== | ==References== | ||
<references/> | <references/> | ||
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[[Category:Drug index]] | [[Category:Drug index]] | ||
[[Category:Oncolytic viral therapy]] | [[Category:Oncolytic viral therapy]] | ||
| − | + | [[Category:Melanoma medications]] | |
[[Category:Drugs FDA approved in 2015]] | [[Category:Drugs FDA approved in 2015]] | ||
Revision as of 06:42, 30 October 2015
General information
Class/mechanism: Genetically modified oncolytic Viral Therapy. Talimogene laherparepvec (Imlygic) is a live, attenuated Herpes Simplex Virus-1 (HSV-1) that has been genetically modified to express human granulocyte-macrophage colony-stimulating factor (huGM-CSF). The modified virus is able to reproduce inside of tumors. The exact mechanism of action is unknown, but the anti-tumor response may be due to the expression of huGM-CSF. It has been observed to cause tumor lysis and release of tumor-derived antigens.[1][2][3][4]
Route: SC
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.
Diseases for which it is used
Patient drug information
History of changes in FDA indication
- 10/27/2015: FDA approved "for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery."
Also Known As
- OncoVEXGM-CSF
- T-VEC
- Imlygic
References
- ↑ 1.0 1.1 Talimogene laherparepvec (Imlygic) package insert
- ↑ Talimogene laherparepvec (Imlygic) package insert (locally hosted backup)
- ↑ Imlygic manufacturer's website
- ↑ Lawler SE, Chiocca EA. Oncolytic Virus-Mediated Immunotherapy: A Combinatorial Approach for Cancer Treatment. J Clin Oncol. 2015;33(25):2812-4. link to original article PubMed