Difference between revisions of "Capmatinib (Tabrecta)"
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==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 | + | *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 [https://clinicaltrials.gov/ct2/show/NCT02414139 Clinical Trial Registry] 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)'' | **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)'' | ||
Revision as of 19:41, 2 June 2023
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 such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), 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 Clinical Trial Registry 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
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.
Also known as
- Code names: INC280
- Generic name: capmatinib
- Brand names: Tabrecta