Enhertu receives recommendation for approval for patients with HER2-mutant advanced non-small cell lung cancer

AstraZenecas Trastuzumab deruxtecan recommended for approval in the EU for a monotherapy for the treatment of adult patients with advanced non-small cell lung cancer whose tumours have an activating HER2  mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.

The CHMP based its positive opinion on the primary results from the DESTINY-Lung02 Phase II trial, which were presented at the IASLC 2023 World Conference on Lung Cancer and simultaneously published in the Journal of Clinical Oncology.

Susan Galbraith, Executive Vice President, AstraZeneca, said: “HER2-mutant non-small cell lung cancer is an aggressive form of lung cancer that often affects younger patients and has a poor prognosis, with limited approved therapies. This milestone recognises the unmet need in the European Union and if approved, Enhertu will provide the first targeted treatment option for these patients.”

Ken Takeshita, Global Head, R&D, Daiichi Sankyo, said: “Enhertu is the first therapy to demonstrate a strong and durable tumour response in patients with previously treated HER2-mutant advanced non-small cell lung cancer, validating HER2 as an actionable target in lung cancer and supporting the potential to provide a much-needed option for these patients. This CHMP opinion is a positive step forward in advancing this HER2-directed antibody drug conjugate for these patients and we look forward to the European Commission decision.”

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