Difference between revisions of "Tepotinib (Tepmetko)"
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==General information== | ==General information== | ||
| − | Class/mechanism: C-Met inhibitor. Inappropriate or constitutive activation of the receptor tyrosine kinase c-Met and its signalling pathway is implicated in many cancers, playing a role in abnormal proliferation, survival, invasion, metastasis, and angiogenesis. | + | Class/mechanism: C-Met inhibitor. Inappropriate or constitutive activation of the receptor tyrosine kinase c-Met and its signalling pathway is implicated in many cancers, playing a role in abnormal proliferation, survival, invasion, metastasis, and angiogenesis.<ref name="insert">[https://www.emdserono.com/us-en/pi/tepmetko-pi.pdf Tepotinib (Tepmetko) package insert]</ref><ref>[[:File:Tepotinib.pdf | Tepotinib (Tepmetko) package insert (locally hosted backup)]]</ref><ref>[https://www.tepmetko.com/ Tepmetko manufacturer's website]</ref> |
<br>Route: PO | <br>Route: PO | ||
<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== | ==Diseases for which it is used== | ||
*[[Non-small cell lung cancer, MET-mutated]] | *[[Non-small cell lung cancer, MET-mutated]] | ||
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| + | ==Patient drug information== | ||
| + | *[https://www.emdserono.com/us-en/pi/tepmetko-pi.pdf Tepotinib (Tepmetko) package insert]<ref name="insert"></ref> | ||
| + | *[http://www.uptodate.com/contents/tepotinib-patient-drug-information Tepotinib (Tepmetko) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/tepotinib-patient-drug-information Tepotinib (Tepmetko) patient drug information (UpToDate)]</ref> | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | *2021-02-03: Granted accelerated approval for adult patients with metastatic [[Non-small cell lung cancer|non-small cell lung cancer (NSCLC)]] harboring [[Biomarkers#MET|mesenchymal-epithelial transition (MET)]] [[Biomarkers#Exon_14|exon 14]] skipping alterations. ''(Based on VISION<sub>NSCLC</sub>)'' |
| + | *2024-02-15: Granted full approval for adult patients with metastatic [[Non-small cell lung cancer|non-small cell lung cancer (NSCLC)]] harboring [[Biomarkers#MET|mesenchymal-epithelial transition (MET)]] [[Biomarkers#Exon_14|exon 14]] skipping alterations. ''(Based on VISION<sub>NSCLC</sub>)'' | ||
| + | ==History of changes in EMA indication== | ||
| + | *2022-02-16: Initial authorization as monotherapy is indicated for the treatment of adult patients with advanced [[Non-small cell lung cancer|non-small cell lung cancer (NSCLC)]] harbouring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. | ||
| + | ==History of changes in Health Canada indication== | ||
| + | *2021-05-27: Initial notice of compliance with conditions for the treatment of adult patients with locally advanced unresectable or metastatic [[Non-small cell lung cancer|non-small cell lung cancer (NSCLC)]] harbouring mesenchymal-epithelial transition (MET) tyrosine kinase receptor exon 14 skipping alterations. | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2020-03-25: Newly indicated for the treatment of unresectable advanced or recurrent MET exon 14 (METex14) skipping mutation-positive [[non-small cell lung cancer]]. | ||
==Also known as== | ==Also known as== | ||
*'''Code names:''' EMD-1214063, MSC-2156119, MSC-2156119J | *'''Code names:''' EMD-1214063, MSC-2156119, MSC-2156119J | ||
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[[Category:Non-small cell lung cancer medications]] | [[Category:Non-small cell lung cancer medications]] | ||
[[Category:FDA approved in 2021]] | [[Category:FDA approved in 2021]] | ||
| + | [[Category:EMA approved in 2022]] | ||
| + | [[Category:Health Canada approved in 2021]] | ||
| + | [[Category:PMDA approved in 2020]] | ||
Revision as of 19:08, 16 February 2024
General information
Class/mechanism: C-Met inhibitor. Inappropriate or constitutive activation of the receptor tyrosine kinase c-Met and its signalling pathway is implicated in many cancers, playing a role in abnormal proliferation, survival, invasion, metastasis, and angiogenesis.[1][2][3]
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.
Diseases for which it is used
Patient drug information
History of changes in FDA indication
- 2021-02-03: Granted accelerated approval for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. (Based on VISIONNSCLC)
- 2024-02-15: Granted full approval for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. (Based on VISIONNSCLC)
History of changes in EMA indication
- 2022-02-16: Initial authorization as monotherapy is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.
History of changes in Health Canada indication
- 2021-05-27: Initial notice of compliance with conditions for the treatment of adult patients with locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition (MET) tyrosine kinase receptor exon 14 skipping alterations.
History of changes in PMDA indication
- 2020-03-25: Newly indicated for the treatment of unresectable advanced or recurrent MET exon 14 (METex14) skipping mutation-positive non-small cell lung cancer.
Also known as
- Code names: EMD-1214063, MSC-2156119, MSC-2156119J
- Brand name: Tepmetko