Objective: Human epidermal growth factor receptor 2 (HER2)-positive breast cancer, which accounts for 20 – 25% of cases of breast cancers, is highly aggressive. Due to cardiotoxicity and increasing resistance associated with...
This is a Phase III, randomized, multicenter, international, 2-arm, open-label clinical trial designed to compare the safety and efficacy of trastuzumab emtansine (T-DM1) with that of capecitabine + lapatinib in participants with...
Seagen Inc. 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.
Seagen Inc.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 (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.
The FDA has approved Kadcyla (trastuzumab emtansine), from Genentech/Roche, for the treatment of people with HER2-positive metastatic Breast Cancer (mBC)...
Odonate Therapeutics announced positive results from CONTESSA, a Phase III study of tesetaxel in patients with metastatic breast cancer (MBC).
Seattle Genetics, Inc. announced the FDA granted approval to Tukysa(tucatinib) tablets in combination with trastuzumab and capecitabine for adult patients with advanced unresectable (cannot be surgically removed) or metastatic HER2-positive breast cancer, including patients with brain metastases (disease that has spread to the brain), who have received one or more prior anti-HER2-based regimens in the metastatic setting.
Seattle Genetics announced that the FDA has accepted for priority review the Company's New Drug Application (NDA) for the investigational...