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.
Sold as Tukysa. Every FDA application for this active ingredient.
As of Nov 14, 2026, FDA lists 1 application for Tucatinib (sold as Tukysa), first approved Apr 17, 2020, with 2 new uses approved and 0 published complete response letters.
First approved: Apr 17, 2020
Applications: 1
New uses approved: 2
Complete response letters: 0
Medicare spending, 2025: $170M
Orphan exclusivity until: Jan 19, 2030
First approved in the EU: Feb 11, 2021
First approved in Japan: Feb 19, 2026
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 70 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
Tukysa, new ingredientDrugs with a new active ingredient indicated for the treatment of human epidermal growth factor receptor 2 (HER2)-positive inoperable or recurrent breast… · Pfizer Japan Inc. · Feb 19, 2026
Clinical Trials
40 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
