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CHMP recommends Enhertu for patients with HER2-positive metastatic breast cancer treated with a prior anti-HER2-based regimen.- Daiichi Sankyo + AstraZeneca
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens.
Trastuzumab emtansine for HER2-positive advanced breast cancer.
Trastuzumab emtansine (T-DM1) is an antibody-drug conjugate incorporating the human epidermal growth factor receptor 2 (HER2)-targeted antitumor properties of trastuzumab with the cytotoxic activity of the microtubule-inhibitory agent DM1.
Trastuzumab emtansine versus treatment of physician's choice for pretreated HER2-positive advanced breast cancer (TH3RESA): a randomised, open-label, phase 3 trial.
Patients with progressive disease after two or more HER2-directed regimens for recurrent or metastatic breast cancer have few effective therapeutic options.
Trastuzumab Deruxtecan Type II variation application validated by EMA for patients with HER2 low metastatic breast cancer with HR positive and HR negative disease .- Daiichi Sankyo + AstraZeneca
Daiichi Sankyo announced that the European Medicines Agency (EMA) has validated the Type II Variation application for trastuzumab deruxtecan as monotherapy for the treatment of adult patients with unresectable or metastatic HER2 low (immunohistochemistry (IHC) 1+ or IHC 2+/in-situ hybridization (ISH)-negative) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.
MHRA (UK) approves Tukysa for the treatment of advanced HER2-positive breast cancer.- Seagen
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Tukysa (tucatinib + trastuzumab + capecitabine), from Seagen, for the treatment of advanced HER2-positive breast cancer.
A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE)
This 2-arm, randomized, open-label study will evaluate the efficacy and safety of trastuzumab emtansine versus trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer who have residual tumor present in...
A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE)
This randomized, 3-arm, multicenter, phase III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) with pertuzumab or trastuzumab emtansine (T-DM1) with pertuzumab-placebo (blinded for pertuzumab), versus...
Seattle Genetics initiates phase III trial ( HER2CLIMB-02) of tucatinib + ado-trastuzumab emtansine to treat metastatic HER2-positive (HER2+) breast cancer.
Seattle Genetics, Inc. announced dosing of the first patient in HER2CLIMB-02, a randomized phase III clinical trial evaluating investigational agent...
Trastuzumab Emtansine for Treating HER2-Positive, Unresectable, Locally Advanced or Metastatic Breast Cancer After Treatment with Trastuzumab and a Taxane: An Evidence Review Group Perspective of a NICE Single Technology Appraisal.
The National Institute for Health and Care Excellence (NICE) invited the manufacturer of trastuzumab emtansine (T-DM1) (Kadcyla®; Roche) to submit...