Difference between revisions of "Talimogene laherparepvec (Imlygic)"
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==General information== | ==General information== | ||
| − | Class/mechanism: Oncolytic | + | 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>[[:File: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. [https://doi.org/10.1200/jco.2015.62.5244 link to original article] [https://pubmed.ncbi.nlm.nih.gov/26215964/ PubMed]</ref> |
| − | <br>Route: SC ( | + | <br>Route: SC (intralesional injection) |
<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. | + | 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> |
| − | name="insert"></ref> | + | |
| + | ==History of changes in FDA indication== | ||
| + | *2015-10-27: [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. ''(Based on OPTiM)'' | ||
| + | ==History of changes in EMA indication== | ||
| + | *2015-12-16: Initial authorization | ||
==Also Known As== | ==Also Known As== | ||
| − | *OncoVEX<sup>GM-CSF</sup> | + | *'''Generic name:''' T-VEC |
| − | + | *'''Brand names:''' Imlygic, OncoVEX<sup>GM-CSF</sup> | |
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==References== | ==References== | ||
<references/> | <references/> | ||
| − | + | ||
| − | + | [[Category:Drugs]] | |
| − | [[Category: | + | [[Category:Intralesional medications]] |
| + | [[Category:Locally delivered therapies]] | ||
| + | |||
[[Category:Oncolytic viral therapy]] | [[Category:Oncolytic viral therapy]] | ||
| − | + | [[Category:Melanoma medications]] | |
| − | [[Category: | + | [[Category:EMA approved in 2015]] |
| + | [[Category:FDA approved in 2015]] | ||
Latest revision as of 17:31, 26 November 2023
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 (intralesional injection)
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
- 2015-10-27: FDA approved for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. (Based on OPTiM)
History of changes in EMA indication
- 2015-12-16: Initial authorization
Also Known As
- Generic name: T-VEC
- Brand names: Imlygic, OncoVEXGM-CSF
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