FDA Grants Breakthrough Therapy Designation for Tucatinib in HER2-Positive Breast Cancer

The FDA granted breakthrough therapy designation to tucatinib in combination with trastuzumab (Herceptin) and capecitabine (Xeloda) for locally advanced or metastatic HER2-positive breast cancer, Seattle Genetics, Inc. announced.¹

This development comes on the heels of an announcement of the HER2CLIMB clinical trial’s results in October 2019, and further data being presented at the 2019 San Antonio Breast Cancer Symposium (SABCS) on December 11. The results were also published in the New England Journal of Medicine.

“The addition of tucatinib to the commonly used combination of trastuzumab and capecitabine demonstrated superior activity compared to trastuzumab and capecitabine alone in patients with unresectable locally advanced or metastatic HER2-positive breast cancer, including those with and without brain metastases,” said Roger Dansey, MD, Chief Medical Officer at Seattle Genetics, in a press release.

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