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.
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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