EMA approves first-line osimertinib for advanced EGFR mutation-positive NSCLC
medwireNews: Osimertinib may now be used as a first-line treatment for locally advanced or metastatic non-small-cell lung cancer (NSCLC) expressing activating EGFR mutations, the EMA says.
The third-generation EGFR tyrosine kinase inhibitor (EGFR–TKI) was initially granted conditional marketing approval in 2015 for use in patients who had developed the EGFR resistance mutation T790M on or after treatment with a first- or second-generation EGFR–TKI, such as gefitinib or afatinib, respectively.
The Committee for Medicinal Products for Human Use has now adopted a positive opinion recommending that the monotherapy’s marketing authorization be extended to include the treatment of patients who test positive for activating EGFR mutations without prior EGFR–TKI use.
The decision follows the US FDA approval of first-line osimertinib earlier this year.
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