(CercleFinance.com) – AstraZeneca announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Agency has recommended the approval of Enhertu (trastuzumab deruxtecan) as a monotherapy intended to treat adult patients with advanced non-small cell lung cancer (NSCLC) with HER2 activating mutation, requiring systemic treatment after platinum-based chemotherapy with or without immunotherapy.
This opinion is based on the main results of a trial that demonstrated a confirmed objective response rate (ORR) of 49.0%.
‘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 important milestone recognizes the unmet need in the European Union and, if approved, Enhertu will provide the first targeted treatment option for these patients,’ responded Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca.
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