CHMP recommends Tagrisso for 1st-line treatment of locally advanced or metastatic NSCLC with activating epidermal growth factor receptor (EGFR) mutations.- AstraZeneca.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion, recommending a change to the terms of the Marketing Authorisation for Tagrisso (osimertinib) from AstraZeneca to include the 1st-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations. The recommendation is based on results from the Phase III FLAURA trial, which were presented at the European Society of Medical Oncology 2017 Congress and published in the New England Journal of Medicine.
See-"Osimertinib in Untreated EGFR-Mutated Advanced Non�Small-Cell Lung Cancer"-Jean-Charles Soria, M.D., Ph.D., Yuichiro Ohe, M.D., Ph.D., Johan Vansteenkiste, M.D., Ph.D., et al., for the FLAURA Investigators-January 11, 2018 N Engl J Med 2018; 378:113-125 DOI: 10.1056/NEJMoa1713137.
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