Benzinga | Dec 11, 2020 07:24AM EST

Seagen Announces Positive CHMP Opinion For TUKYSA For Treatment Of Patients With Locally Advanced Or Metastatic HER2-Positive Breast Cancer

- Recommendation for Approval in the European Union Based on Results of Pivotal HER2CLIMB Trial -

Seagen Inc. (NASDAQ:SGEN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion recommending the approval of TUKYSA(r) (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 2 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.1,2

The CHMP positive opinion will now be considered by the European Commission (EC), which has the authority to approve medicines in the European Union (EU). TUKYSA is approved in the United States, Canada, Switzerland, Singapore and Australia.

"We are pleased the CHMP has recognized TUKYSA as a meaningful clinical advance for people with advanced HER2-positive metastatic breast cancer, including those with cancer that has spread to the brain," said Roger Dansey, M.D., Chief Medical Officer at Seagen. "This opinion brings us one step closer to making TUKYSA available to patients in the EU and aligns with our commitment to bring innovative therapies to patients around the world."

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.