Posted by Michael Wonder on 18 Dec 2019
Seattle Genetics announces U.S. FDA grants breakthrough therapy designation for tucatinib in locally advanced or metastatic HER2-positive breast cancer
18 December 2019 - New drug application submission to U.S. FDA expected by first quarter of 2020.
Seattle Genetics today announced that the U.S. FDA has granted breakthrough therapy designation to tucatinib, in combination with trastuzumab and capecitabine, for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have been treated with trastuzumab, pertuzumab, and T-DM1.
This breakthrough therapy designation was based on data from the pivotal HER2CLIMB clinical trial, which compared tucatinib in combination with trastuzumab and capecitabine to trastuzumab and capecitabine alone in patients with locally advanced unresectable or metastatic HER2-positive breast cancer.
