Posted by Michael Wonder on 24 Dec 2019
Seattle Genetics announces submission of tucatinib new drug application to the U.S. FDA for patients with locally advanced or metastatic HER2 positive breast cancer
23 December 2019 - Submission based on positive pivotal HER2CLIMB trial results recently oresented at the 2019 San Antonio Breast Cancer Symposium and published in the New England Journal of Medicine.
Seattle Genetics today announced it has completed the submission of a new drug application to the U.S. FDA for tucatinib. This application requests FDA approval of 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 received at least three prior HER2-directed agents separately or in combination, in the neo-adjuvant, adjuvant or metastatic setting.
The submission is based on the results of HER2CLIMB, a randomised pivotal trial comparing tucatinib added to trastuzumab and capecitabine versus trastuzumab and capecitabine alone. HER2CLIMB trial results were presented on December 11, 2019 at the 2019 San Antonio Breast Cancer Symposium and published in the New England Journal of Medicine.
