Difference between revisions of "Larotrectinib (Vitrakvi)"
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==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
| − | *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. | + | *9/19/2019: 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. ''(Condition authorisation)'' |
== Patient Drug Information== | == Patient Drug Information== | ||
Revision as of 00:31, 11 May 2021
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 such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.
Diseases for which it is used
History of changes in FDA indication
- 11/26/2018: 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
- 9/19/2019: 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. (Condition authorisation)
Patient Drug Information
Also known as
- Code name: LOXO-101
- Brand name: Vitrakvi