# Neratinib

Source: https://onco.cc/drugs/neratinib/  
OnCo record `neratinib` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A pill taken for a year after trastuzumab to further reduce recurrence in HER2-positive, hormone-positive breast cancer, limited by severe diarrhoea.

## Summary

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.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-07
- Brand: Nerlynx
- Modality: Small-molecule irreversible pan-HER kinase inhibitor
- Mechanism: Irreversible covalent inhibitor of HER1/HER2/HER4 kinases.
- Approvals: US 2017: Extended adjuvant HER2+ early breast cancer after trastuzumab; US 2020: HER2+ metastatic breast cancer with capecitabine after ≥2 anti-HER2 regimens
- Dosing: Oral; 240 mg once daily with food for 1 year (adjuvant); with capecitabine in metastatic
- Toxicity (grade 3+): Diarrhoea 40%

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Neratinib
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Neratinib

## Connected records

- cancers: [HER2-mutant non-small-cell lung cancer](https://onco.cc/cancers/her2-mutant-nsclc/), [HER2-positive breast cancer](https://onco.cc/cancers/breast-her2-positive/), [HER2-positive breast cancer with brain metastases](https://onco.cc/cancers/her2-positive-breast-brain-metastases/)
- technologies: [HER2 tyrosine kinase inhibitors](https://onco.cc/technologies/her2-tyrosine-kinase-inhibitors/), [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [EGFR](https://onco.cc/targets/egfr/), [HER2](https://onco.cc/targets/her2/), [HER4 (ERBB4)](https://onco.cc/targets/erbb4/)
- companies: [Puma Biotechnology](https://onco.cc/companies/puma-biotechnology/)
- terms: [HER2-positive brain metastases](https://onco.cc/terms/her2-brain-metastases/)
- trials: [I-SPY 2](https://onco.cc/trials/i-spy-2/), [INTUITT-NF2](https://onco.cc/trials/intuitt-nf2/), [NALA](https://onco.cc/trials/nala/), [plasmaMATCH](https://onco.cc/trials/plasmamatch/), [SAFIR-ABC10](https://onco.cc/trials/safir-abc10/), [Using Tumor Models to Determine Treatments](https://onco.cc/trials/nct06813079/)
- biomarkers: [HER2 IHC 3+ (HER2-positive by immunohistochemistry)](https://onco.cc/biomarkers/her2-ihc-3-plus/)
- pathways: [Breast cancer (KEGG map)](https://onco.cc/pathways/breast-cancer-signalling/)

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