Tucatinib
A HER2-selective pill that works in the brain, for HER2-positive breast cancer with brain metastases.
HER2CLIMB (with trastuzumab and capecitabine; OS benefit including active brain metastases). Also in HER2+ colorectal cancer with trastuzumab (MOUNTAINEER, 2023). Pfizer (Seagen).
1.Oral drug is absorbed and reaches the tumour
- Route
- Oral
- Schedule
- 300 mg twice daily with trastuzumab and capecitabine (breast) or trastuzumab (colorectal)
- Dose modifications
- Reduce to 250 then 200 mg for hepatotoxicity or diarrhoea
- Monitoring
- LFTs every 3 weeks; diarrhoea management
Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.
- Medicare
- Part D (self-administered)
Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026).
- Commercial insurance
- covered with prior authorisation
Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy.
- Assistance programmes
- Seagen Secure (Pfizer)
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.
Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.
- Appraised for
- With trastuzumab and capecitabine for HER2-positive breast cancer after 2 or more anti-HER2 treatments
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA786 · SMC advice: tucatinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
- 17 Apr 2020ApprovalUS
HER2+ metastatic breast cancer including brain metastases, with trastuzumab and capecitabine (HER2CLIMB) source
- 19 Jan 2023ApprovalUS
HER2+ RAS wild-type metastatic colorectal cancer with trastuzumab (MOUNTAINEER, accelerated) source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2020 | HER2+ metastatic breast cancer including brain metastases, with trastuzumab and capecitabine |
| US | 2023 | HER2+ RAS-wild-type mCRC with trastuzumab |
| Adverse event |
|---|
| Diarrhoea |
| Palmar-plantar erythrodysaesthesia |
| Nausea |
| Fatigue |
| Hepatotoxicity |
| Stomatitis |
HER2CLIMB: 81% any grade, 13% grade 3. Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part D (oral); commercial plans per formulary, often with prior authorisation | not disclosed | pfizeroncologytogether.com |
| United Kingdom | NICE: recommended with trastuzumab and capecitabine for HER2+ breast cancer after ≥2 anti-HER2 regimens (TA786) | not disclosed | — |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
topQuery for this drug: (TITLE:"Tucatinib" OR ABSTRACT:"Tucatinib" OR TITLE:"Tukysa" OR ABSTRACT:"Tukysa") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Tucatinib, not a curated reading list.
Pages like this
not linked directly; found by shared links- TrialDESTINY-Breast12
Shares Systemic-first management of HER2-positive brain metastases, HER2-positive brain metastases, The brain: barrier and sanctuary, HER2-positive breast cancer.
- ProductLorlatinib
Shares Brain metastases included by default in every solid-tumour trial, Prevention trials aimed only at brain metastasis, Organ tropism: seed and soil, The blood–brain barrier & brain metastasis.
- ProductNeratinib
Shares HER2-positive brain metastases, HER2, HER2-positive breast cancer, Small-molecule kinase inhibitors.
- IdeaStop excluding brain metastases from cancer trials
Shares HER2CLIMB, HER2-positive brain metastases, The brain: barrier and sanctuary.
- IdeaDeliver CAR-T cells straight into the fluid around the brain
Shares HER2-positive brain metastases, The brain: barrier and sanctuary, HER2, HER2-positive breast cancer.
- PersonTanios Bekaii-Saab
Shares MOUNTAINEER & MOUNTAINEER-03, HER2, Colorectal cancer.
- ProductAlectinib
Shares Prevention trials aimed only at brain metastasis, The blood–brain barrier & brain metastasis, Small-molecule kinase inhibitors.
- ProductTrastuzumab deruxtecan
Shares CNS penetration (brain-penetrant drugs), Systemic-first management of HER2-positive brain metastases, Brain metastases included by default in every solid-tumour trial, Use the brain's own transport door to carry antibody drugs across.