AstraZeneca and Daiichi Sankyo’s Enhertu approved in EU for treatment of HER2-mutant NSCLC
AstraZeneca and Daiichi Sankyo have announced that Enhertu (trastuzumab deruxtecan) has been approved in the EU as a monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumours have an activating HER2 (ERBB2) mutation and who need systemic therapy following platinum-based chemotherapy with or without immunotherapy.
The drug has been developed collaboratively between AstraZeneca and Daiichi Sankyo as a specifically engineered HER2-directed antibody drug conjugate (ADC) for this indication.
This European Commission (EC) follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) based on data from the DESTINY-Lung02 phase 2 trial, which was shared at the IASLC 2023 World Conference on Lung Cancer and published in the Journal of Clinical Oncology.
Dave Fredrickson, executive vice president of the Oncology Business Unit at AstraZeneca, commented: “Understanding the molecular drivers behind a lung cancer diagnosis is critical, and while there are now targeted options for many patients, those with HER2-mutant NSCLC have had few treatment options, none of which have been approved to treat their specific type of lung cancer. Enhertu is the first HER2-directed option approved for HER2-mutant disease and confirms the relevance of HER2 as a target in lung cancer.”
Ken Keller, global head of Oncology Business, president and CEO at Daiichi Sankyo, added: “Since our initial approval of Enhertu for metastatic breast cancer in the EU more than two years ago, we have remained committed to bringing this innovative antibody drug conjugate to more patients with HER2-targetable tumours, especially those that have previously not been eligible for treatment with a HER2-directed therapy. With today’s news, Enhertu is the first antibody drug conjugate approved for lung cancer in the EU and is now approved in three different tumour types.”
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