Difference between revisions of "Capmatinib (Tabrecta)"
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==General information== | ==General information== | ||
| − | Class/mechanism: Small molecule tyrosine kinase inhibitor, oral cMET inhibitor. | + | Class/mechanism: Small molecule tyrosine kinase inhibitor, oral cMET inhibitor. Inhibits MET (mesenchymal-epithelial transition), including the mutant variant which results from exon 14 skipping. Cells with MET exon 14 skipping have a protein with a missing regulatory domain, which results in reduced negative regulation and therefore increased downstream MET signaling. Capmatinib was demonstrated to inhibit cancer cell growth driven by a mutant MET variant lacking exon 14.<ref name="insert">[https://www.novartis.us/sites/www.novartis.us/files/tabrecta.pdf Capmatinib (Tabrecta) package insert]</ref><ref>[[:File:Capmatinib.pdf | Capmatinib (Tabrecta) package insert (locally hosted backup)]]</ref><ref>[https://www.us.tabrecta.com/ Tabrecta 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 | + | 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 or the prescribing information.<ref name="insert"></ref> |
==Diseases for which it is used== | ==Diseases for which it is used== | ||
| Line 10: | Line 10: | ||
==Patient drug information== | ==Patient drug information== | ||
| − | *[https://www. | + | *[https://www.novartis.us/sites/www.novartis.us/files/tabrecta.pdf Capmatinib (Tabrecta) package insert]<ref name="insert"></ref> |
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | *2020-05-06: [https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-capmatinib-metastatic-non-small-cell-lung-cancer FDA accelerated approval] for the treatment of adult patients with metastatic [[Non-small cell lung cancer|non-small cell lung cancer (NSCLC)]] whose tumors have a mutation that leads to [[Biomarkers#MET|mesenchymal-epithelial transition (MET)]] [[Biomarkers#Exon_14|exon 14]] [[Biomarkers#Deletion|skipping]] as detected by an FDA-approved test. ''(Based on GEOMETRY mono-1)'' |
| + | **2022-08-10: Regular approval for adult patients with metastatic [[Non-small cell lung cancer|non-small cell lung cancer (NSCLC)]] whose tumors have a mutation leading to [[Biomarkers#MET|mesenchymal-epithelial transition (MET)]] [[Biomarkers#Exon_14|exon 14]] [[Biomarkers#Deletion|skipping]]. ''(Based on GEOMETRY mono-1)'' | ||
| + | ==History of changes in EMA indication== | ||
| + | *2022-06-20: Initial authorization as Tabrecta. Tabrecta 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. ''(Based on GEOMETRY mono-1)'' | ||
| + | ==History of changes in Health Canada indication== | ||
| + | *2022-05-26: 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) exon 14 skipping alterations. | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2020-06-29: 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:''' | + | *'''Code names:''' INC-280 |
*'''Generic name:''' capmatinib | *'''Generic name:''' capmatinib | ||
*'''Brand names:''' Tabrecta | *'''Brand names:''' Tabrecta | ||
| Line 28: | Line 35: | ||
[[Category:MET inhibitors]] | [[Category:MET inhibitors]] | ||
| − | |||
[[Category:Non-small cell lung cancer medications]] | [[Category:Non-small cell lung cancer medications]] | ||
[[Category:FDA approved in 2020]] | [[Category:FDA approved in 2020]] | ||
| + | [[Category:EMA approved in 2022]] | ||
| + | [[Category:Health Canada approved in 2022]] | ||
| + | [[Category:PMDA approved in 2020]] | ||
Latest revision as of 01:05, 29 June 2024
General information
Class/mechanism: Small molecule tyrosine kinase inhibitor, oral cMET inhibitor. Inhibits MET (mesenchymal-epithelial transition), including the mutant variant which results from exon 14 skipping. Cells with MET exon 14 skipping have a protein with a missing regulatory domain, which results in reduced negative regulation and therefore increased downstream MET signaling. Capmatinib was demonstrated to inhibit cancer cell growth driven by a mutant MET variant lacking exon 14.[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 or the prescribing information.[1]
Diseases for which it is used
Patient drug information
History of changes in FDA indication
- 2020-05-06: FDA accelerated approval for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test. (Based on GEOMETRY mono-1)
- 2022-08-10: Regular approval for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation leading to mesenchymal-epithelial transition (MET) exon 14 skipping. (Based on GEOMETRY mono-1)
History of changes in EMA indication
- 2022-06-20: Initial authorization as Tabrecta. Tabrecta 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. (Based on GEOMETRY mono-1)
History of changes in Health Canada indication
- 2022-05-26: 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) exon 14 skipping alterations.
History of changes in PMDA indication
- 2020-06-29: 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: INC-280
- Generic name: capmatinib
- Brand names: Tabrecta