Lapatinib
Lapatinib was the first HER2-blocking pill (2007) and is now mostly a comparator arm and a late-line option, displaced by tucatinib and ADCs.
Approved with capecitabine after trastuzumab (EGF100151: TTP 8.4 vs 4.4 months) and with letrozole. Adjuvant ALTTO negative; neoadjuvant NeoALTTO raised pCR but not survival. Diarrhoea and rash; hepatotoxicity warning. The control arm in ACE-Breast-02 and other Chinese ADC trials.
- Route
- Oral
- Schedule
- 1250 mg once daily with capecitabine; 1500 mg with letrozole
- Monitoring
- Liver function, LVEF
- 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). Generic lapatinib is available.
- Commercial insurance
- covered on label
Multi-source generic on low-cost tiers; usually no prior authorisation. Cash prices without insurance are modest. Prior authorisation is uncommon for the generic.
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 an aromatase inhibitor for HER2-positive, HR-positive metastatic breast cancer
- Notes
- Also not recommended with capecitabine after trastuzumab (2010). Rarely used on the NHS.
Sources: NICE TA257. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2007 | HER2+ advanced breast cancer with capecitabine after trastuzumab |
| US | 2010 | HR+/HER2+ metastatic breast cancer with letrozole |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Diarrhoea | 65% | 13% |
| Palmar-plantar erythrodysaesthesia (with capecitabine) | 53% | — |
| Rash | 28% | — |
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.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery for this drug: (TITLE:"Lapatinib" OR ABSTRACT:"Lapatinib" OR TITLE:"Tykerb" OR ABSTRACT:"Tykerb") 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 Lapatinib, not a curated reading list.
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