Posted by Michael Wonder on 02 Feb 2020
EMA validates Seattle Genetics’ marketing authorisation application for tucatinib for patients with locally advanced or metastatic HER2-positive breast cancer
31 January 2020 - Application Supported by Results of Pivotal HER2CLIMB Trial.
Seattle Genetics today announced that the European Medicines Agency (EMA) validated the marketing authorisation application for tucatinib, in combination with trastuzumab and capecitabine, for the treatment of adult patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received at least two prior anti-HER2 treatment regimens.
The EMA validation of the application confirms that the submission is sufficiently complete to begin the formal review process. Tucatinib is an oral, small molecule tyrosine kinase inhibitor that is highly selective for HER2.
