Febuary: “Seagen’s Tukysa (tucatinib) has been approved by the European Commission as part of a triple-combination therapy for people with previously treated advanced or metastatic HER2-positive breast cancer.
The EC approved Tukysa, when given alongside trastuzumab and the chemotherapy medication Xeloda (capecitabine), for patients who have received at least two anti-HER2-based treatments for metastatic disease.
With this decision, Seagen — previously known as Seattle Genetics — will be able to market the Tukysa combo in all European Union (EU) member states, plus Norway, Liechtenstein, Iceland, and Northern Ireland.
“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,” Clay Siegall, PhD, CEO at Seagen, said in a press release.
The U.S. FDA approved Tukysa for the same indication in May 2020.
In December 2020, the Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency, also had supported Tukysa’s approval in the EU.
“This approval is a significant advancement for patients in Europe, who will for the first time have an approved medicine demonstrating a survival benefit for HER2-positive metastatic breast cancer after disease progression following two standard anti-HER2 treatment regimens,” said Volkmar Mueller, MD, deputy director at the University Medical Center Hamburg-Eppendorf, in Germany, a trial investigator.”