EMA validates Type II variation application for Enhertu in non-small cell lung cancer
Daiichi Sankyo announced that the European Medicines Agency (EMA) has validated the Type II Variation application for Enhertu (trastuzumab deruxtecan) as a monotherapy for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations and who have received a prior systemic therapy
Validation confirms that the application is complete and commences the scientific review process by the EMA’s Committee for Medicinal Products for Human Use. This application is based on data from the DESTINY-Lung02 phase II trial presented at the European Society for Medical Oncology (ESMO) 2022 Congress and the DESTINY-Lung01 phase II trial published in The New England Journal of Medicine with updated data also presented at ESMO 2022.
See- "Trastuzumab Deruxtecan in HER2-Mutant Non–Small-Cell Lung Cancer".-Bob T. Li, M.D., Ph.D., M.P.H., Egbert F. Smit, M.D., Ph.D.,et al., for the DESTINY-Lung01 Trial Investigators N Engl J Med 2022, 3January 20, 2022N Engl J Med 2022; 386:241-251, DOI: 10.1056/NEJMoa2112431.
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