Seagen: CHMP Adopts Positive Opinion For TUKYSA - Quick Facts

(RTTNews) - Biotechnology company Seagen Inc. (SGEN) said Friday that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency has adopted a positive opinion for TUKYSA (tucatinib) for the treatment of patients with locally advanced or metastatic HER2-Positive breast cancer.

The CHMP positive opinion recommends the approval of TUKYSA 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 2 prior anti-HER2 treatment regimens.

The CHMP positive opinion will now be considered by the European Commission or EC, which has the authority to approve medicines in the European Union or EU.

TUKYSA is an oral, small molecule tyrosine kinase inhibitor (TKI) of HER2, a protein that contributes to cancer cell growth.

The positive CHMP opinion is based on results of the pivotal trial HER2CLIMB and were published in the New England Journal of Medicine in December 2019.

TUKYSA is approved in the U.S., Canada, Switzerland, Singapore and Australia.