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EU Approves Seagen's Tukysa For Adult Patients With HER2-Positive Metastatic Breast Cancer

Seagen Inc. (SGEN) said Friday that the European Commission has granted marketing authorization for Tukysa or 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.

The approval of Tukysa is valid in all countries of the European Union, as well as Norway, Liechtenstein, Iceland and Northern Ireland.

The company noted that Serious adverse reactions occurred in 26% of patients who received TUKYSA. Serious adverse reactions in =2% of patients who received TUKYSA were diarrhea (4%), vomiting (2.5%), nausea (2%), abdominal pain (2%), and seizure (2%).

Adverse reactions led to treatment discontinuation in 6% of patients who received TUKYSA; those occurring in =1% of patients were hepatotoxicity (1.5%) and diarrhea (1%).

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