Tucatinib Receives FDA Priority Review in HER2-Positive Breast Cancer
Posted: Tuesday, February 18, 2020
On February 13, Seattle Genetics Inc. announced that the U.S. Food and Drug Administration (FDA) approved a Priority Review status for tucatinib in combination with trastuzumab and capecitabine for the treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including those with brain metastases, who have received at least three other HER2-directed agents separately or in combination in the neoadjuvant, adjuvant, or metastatic setting. In December 2019, tucatinib in combination with trastuzumab and capecitabine was granted Breakthrough Therapy designation by the FDA. Tucatinib is an orally administered small molecule tyrosine kinase inhibitor with high selectivity for HER2.
The Priority Review designation was based on results from the HER2CLIMB trial, which were presented at the 2019 San Antonio Breast Cancer Symposium and published in The New England Journal of Medicine. The HER2CLIMB trial compared tucatinib with trastuzumab and capecitabine versus trastuzumab and capecitabine alone. In heavily pretreated patients with HER2-positive metastatic breast cancer, including those with brain metastases, adding tucatinib to trastuzumab and capecitabine resulted in better progression-free and overall survival than adding placebo, according to the study investigators. However, the risk of diarrhea and elevated aminotransferase levels was higher with tucatinib.
