HER2 Breast Cancer

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The Independent Data Monitoring Committee concluded that DESTINY-Breast03 met the primary endpoint of progression-free survival and showed a highly statistically significant and clinically meaningful improvement for patients with human epidermal growth factor receptor 2 (HER2)-positive, unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane.

Officials from the FDA have approved a supplemental New Drug Application (sNDA) for neratinib (NERLYNX, Puma Biotechnology) in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer that have received 2 or more prior anti-HER2-based regimens in the metastatic setting.