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FDA Approval Sought for Neratinib Combo in HER2+ Breast Cancer

Jason M. Broderick @jasoncology
Published: Monday, Jul 01, 2019

Alan H. Auerbach

Alan H. Auerbach

A supplemental new drug application (sNDA) has been submitted to the FDA for neratinib (Nerlynx) for use in combination with capecitabine (Xeloda) for the treatment of patients with HER2-positive metastatic breast cancer who have failed at least 2 prior lines of HER2-directed treatments.

The median duration of treatment was 5.7 months for neratinib compared with 4.4 months for lapatinib. Dose reductions and holds occurred in 24% versus 20% and 48% versus 43% with neratinib versus lapatinib, respectively. The median duration of treatment, dose reductions, and dose holds, were similar for capecitabine between the 2 arms.

All-grade diarrhea occurred in 83% of the neratinib group compared to 66% of the lapatinib arm. Grade 3 diarrhea occurred in 24% versus 13% of the 2 arms, respectively. There were no cases of grade 4 diarrhea reported in either arm. The median time to first onset of grade 2/3 diarrhea was 9 days in the neratinib arm compared with 18 days in the lapatinib arm. The median time to first onset of grade 3 diarrhea was 11 days versus 38 days, respectively.
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