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These highlights do not include all the information needed to use TUKYSA safely and effectively. See full prescribing information for TUKYSA. TUKYSA® (tucatinib) tablets, for oral useInitial U.S. Approval: 2020
Medication labelWhy this: Advisory · dailymed-prescription
TUKYSA is indicated in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. TUKYSA is indicated in combination with trastuzumab for the treatment of adult patients with RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. This indication is approved under accelerated approval based on tumor response rate and durability of response [see Clinical Studies (14.2)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
- generic_name
- tucatinib
- product_names
- tucatinib
- ndc
- 51144-001, 51144-002, 51144-001-60, 51144-002-60, 51144-002-12
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en