Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Treats solid tumors that. Sold as Vitrakvi. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 2 applications for Larotrectinib Sulfate (sold as Vitrakvi), first approved Nov 26, 2018, with 4 new uses approved and 0 published complete response letters.
First approved: Nov 26, 2018
Applications: 2
New uses approved: 4
Complete response letters: 0
Medicare spending, 2025: $55.4M
First approved in the EU: Sep 19, 2019
First approved in Japan: Mar 23, 2021
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 28 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
Vitrakvi, new ingredientDrugs with a new active ingredient indicated for the treatment of NTRK fusion gene-positive advanced or recurrent solid tumors. · Bayer Yakuhin, Ltd. · Mar 23, 2021
Clinical Trials
5 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
Bayer Hlthcare