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| Clinical data | |
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| Trade names | Vitrakvi |
| Other names | LOXO-101, ARRY-470 |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a619006 |
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| Routes of administration | By mouth, oropharyngeal |
| ATC code | |
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| DrugBank | |
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| Chemical and physical data | |
| Formula | C21H22F2N6O2 |
| Molar mass | 428.444 g·mol−1 |
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Larotrectinib, sold under the brand nameVitrakvi, is a medication for the treatment of cancer.[1][5][7] It is an inhibitor oftropomyosin kinase receptorsTrkA,TrkB, andTrkC.[8][9][10] It was discovered byArray BioPharma and licensed toLoxo Oncology in 2013.
Larotrectinib was initially awardedorphan drug status in 2015, for soft tissue sarcoma, andbreakthrough therapy designation in 2016 for the treatment of metastatic solid tumors with NTRK fusion.[11] Some clinical trial results were announced in 2017.[12] On 26 November 2018, Larotrectinib was approved by the FDA.[13]
Larotrectinib was the first drug to be specifically developed and approved to treatany cancer containing certain mutations, as opposed to cancers of specific tissues (i.e., the approval is "tissue agnostic"). Several earlier drugs, includingpembrolizumab, were eventually approved by the FDA for treatment of specific mutations independent of the type of cancer, but those drugs had been initially developed for specific cancer types.[14] The U.S.Food and Drug Administration (FDA) considers it to be afirst-in-class medication.[15]
Larotrectinib was approved for medical use in the European Union in September 2019.[16][6] It was approved for medical use in Australia in August 2020.[1]
Phase II clinical trials evaluating the drug for efficacy and safety in treating several types of solid tumors are ongoing.[17]
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