Prescription medicine
Tucatinib Brand names: Tukysa
Tucatinib (Tukysa) is a prescription medicine with an FDA approval on record since 2020. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the tucatinib FDA label on DailyMed (effective November 4, 2024, SEAGEN INC.); the NDA 213411 record on Drugs@FDA; every tucatinib label on DailyMed.
Highlights of the record
FDA label of November 4, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageTUKYSA is a kinase inhibitor 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.
Forms and strengths
- 50 mg
- 150 mg
Tablet.
On the market
- Earliest approval on file
- April 17, 2020 Tukysa, Seagen; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- April 27, 2038 Tukysa tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 6,932 through July 30, 2026
What is tucatinib used for?
From the label: indications and usageTUKYSA is a kinase inhibitor 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. ( 1.1 )
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. […]
Conditions named in the indications of tucatinib's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (TUKYSA), SEAGEN INC., effective November 4, 2024 (SPL set f27eb1b9-b7fc-424e-988f-84dd7bb195a3), via openFDA; the full label on DailyMed
Is there a generic for tucatinib (Tukysa)?
No generic tucatinib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 7 patents for Tukysa tablets: the compound patent runs to April 17, 2034, and the last listed entry to April 27, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2020 earliest approval on file
- 2038 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the tucatinib label say about other medicines?
The tucatinib label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Capecitabine | warnings and precautions | Advise patients of potential risk to a fetus and to use effective contraception. ( 5.3 , 8.1 , 8.3 ) Also, refer to the Full Prescribing Information of trastuzumab and capecitabine for pregnancy and contraception information. |
| Trastuzumab | warnings and precautions | Advise patients of potential risk to a fetus and to use effective contraception. ( 5.3 , 8.1 , 8.3 ) Also, refer to the Full Prescribing Information of trastuzumab and capecitabine for pregnancy and contraception information. |
Source: FDA drug label (TUKYSA), SEAGEN INC., effective November 4, 2024 (SPL set f27eb1b9-b7fc-424e-988f-84dd7bb195a3), via openFDA; the full label on DailyMed
What do FAERS reports show for tucatinib?
The FDA Adverse Event Reporting System holds 6,932 reports that list tucatinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 708 are coded as a death and 1,881 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as tucatinib?
19 other medicines are given the same way (oral) and in the same FDA class as tucatinib or labeled mainly for the same use (breast cancer), the same class first. Breast cancer lists all 44 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Everolimus | Breast cancer | 14 labelers | $26.32 per tablet 10 mg tablet | A presentation being discontinued |
| Palbociclib | Breast cancer | none listed | n/a | A presentation being discontinued |
| Abemaciclib | Breast cancer | none listed | n/a | No current entry |
| Lapatinib ditosylate | Breast cancer | 3 labelers | n/a | No current entry |
| Ribociclib | Breast cancer | none listed | $289.72 per unit 600 mg daily dose | No current entry |
| Neratinib | Breast cancer | none listed | n/a | No current entry |
| Regorafenib | Colorectal cancer | none listed | n/a | No current entry |
| Anastrozole | Breast cancer | 24 labelers | $0.142 per tablet 1 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to tucatinib
- 19 medicines for the same use
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Tucatinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other