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FDA Accepts sNDA for Neratinib Combo for HER2+ Breast Cancer

Jason M. Broderick @jasoncology
Published: Wednesday, Sep 11, 2019

Alan H. Auerbach

Alan H. Auerbach

The FDA has accepted a supplemental new drug application (sNDA) 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.

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Response data were available for 256 patients in the neratinib arm and 270 patients in the lapatinib arm. The objective response rate was 33% in the neratinib arm versus 27% in the lapatinib group. The clinical benefit rate was 45% versus 36%, respectively. The median duration of response was 8.5 months versus 5.6 months in the neratinib versus lapatinib arms, respectively.

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