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The FDA has approved a supplemental new drug application for neratinib in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received ≥2 prior anti–HER2-based regimens in the metastatic setting.

The FDA has granted a priority review designation to a new drug application for tucatinib for use in combination with trastuzumab and capecitabine for the treatment of patients with unresectable locally advanced or metastatic HER2-positive breast cancer, including patients with brain metastases, following at least 3 prior HER2-directed agents separately or in combination, in the neoadjuvant, adjuvant, or metastatic setting.

The European Medicines Agency has validated a Marketing Authorization Application for tucatinib in combination with trastuzumab and capecitabine for the treatment of adult patients with unresectable locally advanced or metastatic HER2-positive breast cancer, including those with brain metastases, who have received ≥2 prior anti-HER2 treatment regimens.

Sara A. Hurvitz, MD, associate professor at the David Geffen School of Medicine, University of California, Los Angeles (UCLA) medical director of the Jonsson Comprehensive Cancer Center Clinical Research Unit, co-director of the Santa Monica-UCLA Outpatient Oncology Practices, and director, Breast Cancer Clinical Trials Program, UCLA, discusses the evolution of treatment in metastatic HER2-positive breast cancer.