Seagen International (Seagen) has announced that the European Commission (EC) has approved a marketing authorisation for its HER2 tyrosine kinase inhibitor (TKI) Tukysa for the treatment of HER2-positive locally-advanced or metastatic breast cancer.
The EC has approved the use of Tukysa (tucatinib) in combination with trastuzumab and capecitabine for the treatment of adult patients with advanced HER2-positive breast cancer, who have received at least two prior anti-HER2 treatments.
In Seagen’s HER2CLIMB trial of Tukysa, patients who received the TKI in combination with trastuzumab and capecitabine had a 46% reduction in the risk of cancer progression or death – progression-free survival (PFS).
Patients in the Tukysa treatment group also experienced improved overall survival, with a reduction in the risk of death by 34%.
“The Tukysa combination is a landmark therapy for patients with HER2-positive metastatic breast cancer with or without brain metastases, extending overall survival in these patients after two prior anti-HER2-treatment regimens,” said Clay Siegall, chief executive officer at Seagen.
“We are pleased Tukysa is now approved in Europe, and we look forward to further collaborating with individual countries to ensure it is available to patients,” he added.