EMA validates MAA for tucatinib, + trastuzumab + capecitabine, to treat locally advanced unresectable or metastatic HER2-positive breast cancer, including brain metastases. Seattle Genetics

Seattle Genetics, Inc.has announced that the European Medicines Agency (EMA) validated the Marketing Authorization Application (MAA) 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 MAA confirms that the submission is sufficiently complete to begin the formal review process. Tucatinib is an oral, small molecule tyrosine kinase inhibitor (TKI) that is highly selective for HER2. The MAA is 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. Patients had previously received trastuzumab, pertuzumab and T-DM1 (ado-trastuzumab emtansine). Patients had received a median of four prior lines of therapy overall and three in the metastatic setting. Forty-seven percent of the patients enrolled in the trial had brain metastases at the time of enrollment. Results of the pivotal HER2CLIMB trial were presented during an oral presentation at the 2019 San Antonio Breast Cancer Symposium (SABCS) and simultaneously published in the New England Journal of Medicine(NEJM).