Difference between revisions of "Larotrectinib (Vitrakvi)"
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<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. |
| − | == | + | ==Diseases for which it is used== |
| − | + | *[[Malignant solid neoplasm, NTRK-mutated|Solid malignancies with NTRK fusions]] | |
| − | # | + | |
| − | # | + | ==History of changes in FDA indication== |
| + | *2018-11-26: Granted accelerated approval for adult and pediatric patients with [[:Category:Malignant solid neoplasm|solid tumors]] that have a [[Biomarkers#NTRK|neurotrophic tyrosine receptor kinase (NTRK) gene]] [[Biomarkers#Rearrangement|fusion]] without a known acquired resistance mutation, that are either metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory alternative treatments or whose cancer has progressed following treatment. ''(Based on LOXO-TRK-14001, SCOUT, and NAVIGATE)'' | ||
| + | |||
| + | ==History of changes in EMA indication== | ||
| + | *2019-09-19: Initial conditional authorisation as Vitrakvi. Vitrakvi as monotherapy is indicated for the treatment of adult and paediatric patients with [[:Category:Malignant solid neoplasm|solid tumours]] that display a [[Biomarkers#NTRK|Neurotrophic Tyrosine Receptor Kinase (NTRK) gene]] [[Biomarkers#Rearrangement|fusion]], who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory treatment options. | ||
| + | ==History of changes in Health Canada indication== | ||
| + | *2019-07-10: Initial notice of compliance with conditions for the treatment of adult and pediatric patients with [[:Category:Malignant solid neoplasm|solid tumours]] that have a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic, or where surgical resection is likely to result in severe morbidity, and have no satisfactory treatment options. | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2021-03-23: Newly indicated for the treatment of NTRK fusion gene-positive advanced or recurrent [[:Category:Malignant solid neoplasm|solid tumours]]. | ||
| + | ==Patient Drug Information== | ||
| + | *[https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211710s000lbl.pdf Larotrectinib (Vitrakvi) Package Insert]<ref>[https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211710s000lbl.pdf Larotrectinib (Vitrakvi) Package Insert]</ref> | ||
| + | |||
| + | ==Also known as== | ||
| + | *'''Code name:''' LOXO-101 | ||
| + | *'''Brand name:''' Vitrakvi | ||
| + | |||
| + | ==References== | ||
| + | |||
| + | [[Category:Drugs]] | ||
| − | |||
| − | |||
[[Category:Oral medications]] | [[Category:Oral medications]] | ||
| − | + | ||
[[Category:TRK inhibitors]] | [[Category:TRK inhibitors]] | ||
| − | [[Category: | + | [[Category:Mutation-specific medications]] |
| + | [[Category:Malignant solid neoplasm, NTRK-mutated medications]] | ||
| − | [[Category: | + | [[Category:FDA approved in 2018]] |
| + | [[Category:EMA approved in 2019]] | ||
| + | [[Category:Health Canada approved in 2019]] | ||
| + | [[Category:PMDA approved in 2021]] | ||
Latest revision as of 01:01, 29 June 2024
General information
Class/mechanism from the NCI Drug Dictionary: An orally available, tropomyosin receptor kinase (Trk) inhibitor, with potential antineoplastic activity. Upon administration, larotrectinib binds to Trk, thereby preventing neurotrophin-Trk interaction and Trk activation, which results in both the induction of cellular apoptosis and the inhibition of cell growth in tumors that overexpress Trk.
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.
Diseases for which it is used
History of changes in FDA indication
- 2018-11-26: Granted accelerated approval for adult and pediatric patients with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, that are either metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory alternative treatments or whose cancer has progressed following treatment. (Based on LOXO-TRK-14001, SCOUT, and NAVIGATE)
History of changes in EMA indication
- 2019-09-19: Initial conditional authorisation as Vitrakvi. Vitrakvi as monotherapy is indicated for the treatment of adult and paediatric patients with solid tumours that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory treatment options.
History of changes in Health Canada indication
- 2019-07-10: Initial notice of compliance with conditions for the treatment of adult and pediatric patients with solid tumours that have a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic, or where surgical resection is likely to result in severe morbidity, and have no satisfactory treatment options.
History of changes in PMDA indication
- 2021-03-23: Newly indicated for the treatment of NTRK fusion gene-positive advanced or recurrent solid tumours.
Patient Drug Information
Also known as
- Code name: LOXO-101
- Brand name: Vitrakvi