Tucatinib is an oral HER2-targeted kinase inhibitor taken twice daily. In the United States it is approved as Tukysa for HER2-positive breast cancer (in combination with trastuzumab and capecitabine, or as maintenance with trastuzumab and pertuzumab) and, under accelerated approval, for RAS wild-type HER2-positive colorectal cancer.[1]
This page explains the medicine using official sources and lists 5 products as listed by Medicine for World and a manufacturer page in Bangladesh. The originator Tukysa is described from the official label. It is not a complete global list, and regulatory status differs by product and country.[4]
Availability enquiries are handled by Medicine for World. Submission of an enquiry does not confirm regulatory eligibility, supply or delivery. Ownership and commercial disclosure
Tucatinib is the international non-proprietary name of an oral kinase inhibitor that targets HER2. According to the US prescribing information, Tukysa is indicated for HER2-positive breast cancer – together with trastuzumab and capecitabine in advanced unresectable or metastatic disease after one or more prior anti-HER2 regimens (including brain metastases), and, since October 2026, together with trastuzumab and pertuzumab as maintenance after induction therapy – and, with trastuzumab, for RAS wild-type HER2-positive colorectal cancer that progressed after chemotherapy. The colorectal use is an accelerated approval based on response rate and durability of response.[1][4]
In the European Union, where it is authorised as Tukysa (11 February 2021), the listed use is in combination with trastuzumab and capecitabine for adults with locally advanced or metastatic HER2-positive breast cancer who have had at least two prior anti-HER2 regimens.[3] Tukysa was first approved in the United States on 17 April 2020.[2] Approved uses and available strengths differ between countries.
In the HER2CLIMB trial, median overall survival was 21.9 months with Tukysa versus 17.4 months with placebo (hazard ratio 0.66), and median progression-free survival was 7.8 versus 5.6 months (hazard ratio 0.54).[1] Whether tucatinib is suitable, and at which dose, is decided by the treating doctor. Full warnings are in the official product information:
The products below are included for identification and availability-enquiry purposes. Inclusion does not mean that a product is authorised, approved, therapeutically equivalent or available in every country. Confirm regulatory status with the relevant national medicines authority.
Products are listed in alphabetical order. The list is not a ranking and makes no claim that one product is better than another.[4]
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Product listing data last checked October 14, 2026.
Tukysa is the originator tucatinib medicine, first approved by the US FDA on 17 April 2020 under Seagen, now part of Pfizer. In the European Union it was authorised on 11 February 2021 (Pfizer Europe MA EEIG). The originator itself is not part of the Medicine for World listing on this page; its card links to the official US prescribing information. Other products represented as containing tucatinib are made by other manufacturers and sold under their own brand names.[1][2][3]
The originator is shown here separately from the other listed products.
This comparison covers identity and listing information only. It does not establish regulatory approval, pharmaceutical equivalence, bioequivalence, quality, safety or clinical effectiveness.
| Attribute | Other listed tucatinib products | Originator (Tukysa) |
|---|---|---|
| Active substance | Tucatinib, as listed. Formulation details are not fully stated in some product listings.[4] | Tucatinib[1] |
| Brand name | Each manufacturer's own brand name (5 products listed, for example Tucaxen, Tukanic, LuciTuca)[4] | Tukysa (US and EU)[1][3] |
| Company | Everest, Ziska, Lucius, Bigbear and Beacon as named in the listings; manufacturing country listed: Bangladesh for Everest, Ziska and Beacon, Laos for Lucius and Bigbear[4] | Seagen / Pfizer[1][3] |
| Dosage form | Tablet, as listed[4] | Film-coated tablets (US label)[1] |
| Strength | 150 mg for all listed products[4] | Tablets 50 mg and 150 mg (US label)[1] |
| Pack | 30 or 60 tablets per pot, or 28 tablets per blister box, as listed[4] | Not listed by Medicine for World[4] |
| Regulatory approval | Varies by product and country. Not independently verified for this page. Check with your national medicines authority. | US FDA approval 17 April 2020 · EU authorisation 11 February 2021[2][3] |
| Classification | Product represented by its manufacturer or supplier as containing tucatinib. Regulatory classification must be confirmed in the relevant jurisdiction.[4] | Originator product[1][2] |
| What must be the same | Same active ingredient, strength, dosage form and route of administration as the originator, where the product is approved as a generic[5] | Reference product[1] |
| Bioequivalence | Must deliver the same amount of active ingredient at the same rate and extent as the originator[5][6] | Reference product for the comparison[6] |
| Clinical trial data | Does not have to repeat the originator's animal and clinical studies; shows equivalence to the originator instead[5][6] | Full safety and efficacy programme submitted for approval[2][6] |
| Inactive ingredients and appearance | May differ (for example colour or excipients); minor differences are generally allowed and rarely matter clinically[6] | Its own formulation and appearance[1] |
| Manufacturing standards | Made under the same strict good-manufacturing-practice standards as the originator; plants are inspected[5] | Same standards[5] |
| Price | Tends to cost less, because the maker does not repeat the original studies[5]. No prices are shown on this page. | Usually higher[5] |
| Market entry | Generally approved once the originator's patents and exclusivities have expired or been successfully challenged[5] | Protected by patents and marketing exclusivity during that period[5] |
The information below summarises the US prescribing information. It is not complete; read the full label and talk to your doctor.[1]
| Side effect | Share of patients |
|---|---|
| Diarrhea | 81% (placebo 53%) |
| Palmar-plantar erythrodysesthesia (hand-foot syndrome) | 63% (placebo 53%) |
| Nausea | 58% (placebo 44%) |
| Hepatotoxicity | 42% (placebo 24%) |
| Vomiting | 36% (placebo 25%) |
| Stomatitis | 32% (placebo 21%) |
| Decreased appetite | 25% (placebo 20%) |
| Anemia | 21% (placebo 13%) |
Tucatinib is taken by mouth twice a day, about 12 hours apart, with or without food, swallowed whole. Your doctor decides the dose and the treatment duration.[1]
| Use | Daily dose | Notes |
|---|---|---|
| All indications | 300 mg twice daily | Two 150 mg tablets twice daily; until disease progression or unacceptable toxicity |
| HER2-positive breast cancer, after prior anti-HER2 therapy | 300 mg twice daily | Together with trastuzumab and capecitabine; capecitabine 1000 mg/m² twice daily within 30 minutes after a meal on days 1–14 of each 21-day cycle |
| HER2-positive breast cancer, maintenance | 300 mg twice daily | Together with trastuzumab and pertuzumab after induction therapy |
| RAS wild-type HER2-positive colorectal cancer | 300 mg twice daily | Together with trastuzumab; HER2 and RAS status are confirmed before starting |
| Adverse reaction needing a lower dose | 250 mg, then 200 mg, then 150 mg twice daily | Stop treatment if 150 mg twice daily is not tolerated |
| With a strong CYP2C8 inhibitor | Avoid; if unavoidable, 100 mg twice daily | Return to the previous dose after the inhibitor is stopped |
| Severe liver impairment (Child-Pugh C) | 200 mg twice daily | Liver tests are monitored before and during treatment |
The doses in the table are US label information, not a personal recommendation. Tablets are 50 mg and 150 mg.[1]
Tucatinib is a kinase inhibitor that selectively blocks the HER2 receptor, which drives growth in HER2-positive cancer cells.[1]
It is used together with other HER2-directed medicines (trastuzumab, with capecitabine or pertuzumab) depending on the cancer type and stage, as set out in the label.[1]
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Tucatinib is a prescription-only, twice-daily oral HER2-targeted kinase inhibitor for HER2-positive cancer. The originator brand is Tukysa, made by Seagen (now Pfizer).
In the US label, Tukysa is used for HER2-positive breast cancer (with trastuzumab and capecitabine after prior anti-HER2 treatment, or as maintenance with trastuzumab and pertuzumab) and, as an accelerated approval, for RAS wild-type HER2-positive colorectal cancer with trastuzumab. The EU lists the breast-cancer use after at least two prior anti-HER2 regimens. Approved uses differ by country.
Seagen, now part of Pfizer. Tukysa was first approved in the United States on 17 April 2020 and authorised in the European Union on 11 February 2021 (Pfizer Europe MA EEIG).
The US label says 300 mg twice daily, about 12 hours apart, with or without food, swallowed whole, until disease progression or unacceptable toxicity. Doses change after certain adverse reactions, in severe liver impairment and with some interacting medicines.
In the HER2CLIMB trial in the US label, diarrhea (81%), hand-foot syndrome (63%), nausea (58%), liver toxicity (42%) and vomiting (36%) were among the most frequent.
Yes. The current US label has a boxed warning for severe and fatal liver injury (hepatotoxicity). It also warns about severe diarrhea, embryo-fetal toxicity and a rise in serum creatinine without true kidney damage.
Strong CYP2C8 inhibitors (such as gemfibrozil) raise tucatinib levels, while strong CYP3A inducers (such as rifampin) lower them. Tucatinib itself raises the levels of CYP3A substrates such as midazolam. Ask your doctor or pharmacist about everything you take.
5 products represented by their manufacturers or suppliers as containing tucatinib (Tucaxen, Tukanic, LuciTuca, Tucadx, Tucatin). It is not a complete global list, and inclusion does not mean that a product is authorised in any specific country.
Equivalence is established by the regulator product by product, through bioequivalence data compared with the originator, so it cannot be assumed from a listing alone. The listed products are represented by their manufacturers as containing tucatinib. Their regulatory status and equivalence to Tukysa should be confirmed with your national medicines authority and your doctor.
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Medical and regulatory facts come from official product information. Product listing details come from a supplied dataset. Numbers in square brackets on this page refer to the sources below.