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AstraZeneca : Enhertu approved in the EU as first tumour agnostic HER2-directed therapy and antibody drug conjugate for patients with previously treated HER2-positive metastatic solid tumours
AstraZeneca : Enhertu approved in the EU as first tumour agnostic HER2-directed therapy and antibody drug conjugate for patients with previously treated
About this update from Astrazeneca Plc
Based on three Phase II trials of AstraZeneca and Daiichi Sankyo's Enhertu which demonstrated clinically meaningful responses across a broad range of tumours AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) has been approved in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive (immunohistochemistry [IHC] 3+) solid tumours who have received prior treatment and who have no satisfactory treatment options. The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and is based on results from a subgroup of patients with HER2-positive (IHC 3+) tumours across three Phase II trials, DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02. Benedikt Westphalen, MD, Head of the Precision Oncology Program, Comprehensive Cancer Center of the University of Munich, Germany, said: "HER2 overexpression occurs across multiple tumour types and is associated with aggressive disease and a poor prognosis. Until now, HER2-directed therapies were only available for specific tumour types. The approval of trastuzumab deruxtecan as a tumour-agnostic therapy opens a new treatment option for patients with HER2-positive cancers regardless of where the tumour originated." Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: "Precision medicine is reshaping cancer care by helping inform treatment decisions based on the molecular and biological characteristics of a patient's disease. Enhertu is already approved in breast, gastric, and lung cancers, and with this approval, clinicians may now consider Enhertu for patients with HER2-positive status across multiple additional tumour types. This highlights the importance of biomarker testing to identify eligible patients and ensure that those with HER2-positive disease are considered for targeted treatment." Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc., said: "This approval of Enhertu marks a significant milestone in the EU for patients with HER2-positive metastatic solid tumours and establishes the first tumour-agnostic indication for a HER2-directed therapy and antibody drug conjugate in the region. Enhertu is now approved for six indications in the EU, whi...