The Food and Drug Administration (FDA) has approved a labeling supplement for Nerlynx (neratinib; Puma Biotechnology) to include safety information regarding neratinib-associated diarrhea. 

Nerlynx is a kinase inhibitor indicated for the extended adjuvant treatment of adult patients with early-stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer, to follow adjuvant trastuzumab based therapy. The new safety information is based on interim data from the phase 2 CONTROL trial, an ongoing study evaluating the incidence and severity of diarrhea in patients with early-stage HER2-positive breast cancer (N=750) receiving neratinib with loperamide, alone and in combination with an anti-inflammatory agent (budesonide) or a bile acid sequestrant (colestipol).

At the interim analysis, the incidence of all grade diarrhea for patients receiving loperamide alone (n=109) was 78% compared with 86% of patients who received budesonide and loperamide (n=64); the incidence of Grade 3 diarrhea was 32% compared with 28%, respectively. Diarrhea leading to treatment discontinuation occurred in 18% of patients treated with loperamide alone compared with 11% of the patients who received loperamide and budesonide.

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Based on these findings, the prescribing information for Nerlynx has been updated to include the new data that supports the use of other agents (budesonide) to loperamide if clinically indicated.


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“We believe FDA approval of the labeling supplement will help us to ensure that physicians and patients are better informed in selecting prophylactic therapy that may improve the tolerability of the drug,” said Alan H. Auerbach, CEO and President of Puma Biotechnology. 

For more information visit nerlynx.com.