AstraZeneca: CHMP recommends apprival of Enhertu
(CercleFinance.com) - AstraZeneca has announced that the European Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Enhertu (trastuzumab deruxtecan) as monotherapy for the treatment of adult patients with HER2-activated advanced non-small cell lung cancer (NSCLC) requiring systemic therapy after platinum-based chemotherapy with or without immunotherapy.
This opinion is based on the main results of a trial demonstrating a confirmed objective response rate (ORR) of 49.0%.
AstraZeneca said that 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.
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