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24-07-2017 | FDA | News

approvalsWatch

Extended neratinib adjuvant therapy approved for HER2-positive breast cancer

medwireNews: The dual HER2 and EGFR kinase inhibitor neratinib has received US FDA approval for use in patients with early-stage HER2-positive breast cancer who have previously received adjuvant therapy including trastuzumab.

The extended adjuvant treatment approval is based upon preliminary results for the ongoing ExteNET study comparing the outcome of 2840 patients given neratinib versus placebo after an initial 2 years of trastuzumab. After 2 years of treatment, 94.2% of the patients using neratinib were alive and free from recurrence versus 91.9% of controls.

The FDA recommends that patients should be given loperamide for diarrhea management over the first 56 days of neratinib therapy.

By Lynda Williams

medwireNews is an independent medical news service provided by Springer Healthcare. © 2017 Springer Healthcare part of the Springer Nature group

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