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A pill taken for a year after trastuzumab to further reduce recurrence in HER2-positive, hormone-positive breast cancer, limited by severe diarrhoea.
ExteNET: extended adjuvant neratinib for 1 year after trastuzumab improved 5-year iDFS (90.2% vs 87.7%, HR 0.73), with benefit concentrated in HR+ disease that started within a year of trastuzumab. NALA (with capecitabine, metastatic): PFS HR 0.76 and fewer CNS interventions. Grade 3 diarrhoea ~40% without prophylaxis; loperamide prophylaxis or dose escalation (CONTROL) mitigates it.
Irreversible covalent inhibitor of HER1/HER2/HER4 kinases. Connects to HER2 and EGFR.
1.Neratinib slips into a pocket on HER2.
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).
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.
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.
Sources: NICE TA612 · SMC advice: neratinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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| Region | Year | Indication |
|---|---|---|
| US | 2017 | Extended adjuvant HER2+ early breast cancer after trastuzumab |
| US | 2020 | HER2+ metastatic breast cancer with capecitabine after ≥2 anti-HER2 regimens |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Diarrhoea | 95% | 40% |
| Nausea | 43% | - |
| Fatigue | 27% | - |
without prophylaxis; ~15% grade 3 with escalation. 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.
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Query for this drug: (TITLE:"Neratinib" OR ABSTRACT:"Neratinib" OR TITLE:"Nerlynx" OR ABSTRACT:"Nerlynx") 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 Neratinib, not a curated reading list.
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