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European Commission Approves Seagens TUKYSA (tucatinib) for the Treatment of Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer

Seagen Inc. (Nasdaq:SGEN) today announced that the European Commission (EC) has granted marketing authorization for TUKYSA
® (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.
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“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 Prof. Dr. Med Volkmar Mueller, Deputy Director at the University Medical Center Hamburg-Eppendorf, Hamburg, Germany and investigator for the pivotal trial. “In the HER2CLIMB pivotal trial, the tucatinib combinat ....

Nordrhein Westfalen , United States , Janelle Taylor , Clay Siegall , Peggy Pinkston , Anita Kulukian , Volkmar Mueller , Patrice Lee , European Commission , World Health Organization , Lab Abnormalities , University Medical Center Hamburg , Seagen Inc , Exchange Commission , European Union , European Medicines Agency , Committee For Medicinal Products Human Use , American Cancer Society , Med Volkmar Mueller , Deputy Director , University Medical Center Hamburg Eppendorf , Chief Executive Officer , Medicinal Products , Human Use , Positive Breast , Fetal Toxicity ,

European Commission Approves Seagen's TUKYSA® (tucatinib) for the Treatment of Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer

Published: Feb 12, 2021
European Commission Approves Seagen’s TUKYSA
® (tucatinib) for the Treatment of Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer
- Approved for Adult Patients with HER2-Positive Metastatic Breast Cancer Who Have Received at Least Two Prior Anti-HER2 Treatment Regimens -
- First HER-2 Tyrosine Kinase Inhibitor Combination Regimen to Improve Overall and Progression-Free Survival in Previously Treated Patients with Metastatic HER2-Positive Breast Cancer With or Without Brain Metastases -

BOTHELL, Wash. (BUSINESS WIRE) Seagen, Inc. (Nasdaq:SGEN) today announced that the European Commission (EC) has granted marketing authorization for TUKYSA
® (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 molec ....

Nordrhein Westfalen , United States , Janelle Taylor , Clay Siegall , Anita Kulukian , Volkmar Mueller , Patrice Lee , European Commission , World Health Organization , Lab Abnormalities , University Medical Center Hamburg , Seagen Inc , Exchange Commission , European Union , European Medicines Agency , Committee For Medicinal Products Human Use , American Cancer Society , Med Volkmar Mueller , Deputy Director , University Medical Center Hamburg Eppendorf , Chief Executive Officer , Medicinal Products , Human Use , Positive Breast , Fetal Toxicity , Hepatic Impairment ,