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Neratinib in Early-Stage Breast Cancer: A Profile of Its Use in the EU

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posted on 2018-12-05, 00:57 authored by Sohita Dhillon

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Funding The preparation of this review was not supported by any external funding.

Disclosure The preparation of this review was not supported by any external funding. Sohita Dhillon is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.

Additional information about this Adis Drug Review can be found here.


Neratinib (Nerlynx®) is an oral, irreversible tyrosine kinase inhibitor of human epidermal growth factor receptor 1 (HER1), HER2 and HER4. Neratinib therapy for 12 months significantly reduced the risk of invasive disease recurrence or death relative to placebo at both 2 and 5 years post-randomization in the pivotal ExteNET trial in women with early-stage HER2-positive breast cancer who had completed adjuvant trastuzumab. Subgroup analyses showed that patients with hormone receptor (HRc)-positive disease derived greater benefit with neratinib than patient with HRc-negative disease, and patients who initiated neratinib within 1 year of completing trastuzumab had better outcomes than those who started treatment 1–2 years after trastuzumab. This led to the approval of neratinib in the EU as extended adjuvant therapy for patients with early-stage hormone receptor (HRc)-positive, HER2-positive breast cancer and who are < 1 year from completion of prior adjuvant trastuzumab-based therapy. It is the first agent of its class to be approved in the EU in this setting. As with other tyrosine kinase inhibitors, diarrhoea, which was manageable with antidiarrhoeal prophylaxis and/or dose modifications, was the most common any-grade or grade ≥ 3 treatment-emergent adverse event with neratinib,. Although the exact position of neratinib relative to other adjuvant therapies remains to be determined, it provides a valuable option to reduce the risk of recurrence in this setting and has been included in the updated ESMO patient guide as an extended adjuvant therapy for some patients.

© Springer Nature Switzerland AG 2018


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