European Commission approves Tukysa + trastuzumab and capecitabine to treat HER2-positive locally advanced or metastatic breast cancer.- Seagen Inc.

Seagen Inc. announced that the European Commission (EC) has granted marketing authorization for Tukysa (tucatinib) in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have received at least two prior anti-HER2 treatment regimens. Tukysa is an oral, small molecule tyrosine kinase inhibitor (TKI) of HER2, a protein that contributes to cancer cell growth. Patients who received Tukysa in combination with trastuzumab and capecitabine in the pivotal trial had a 46 percent reduction in the risk of cancer progression or death (PFS), the primary endpoint, compared to patients who received trastuzumab and capecitabine alone (hazard ratio (HR)=0.54 [95% Confidence Interval (CI): 0.42, 0.71]; p<0.00001) and improved overall survival with a reduction in the risk of death by 34 percent (hr="0.66" [95% ci: 0.50, 0.87]; p="0.0048)." the most common adverse reactions occurring in 20 percent or more of patients who received tukysa were diarrhea, nausea, vomiting, stomatitis, ast increase, alt increase, and rash.>