medwireNews: The EMA recommends adopting a new indication for osimertinib as adjuvant therapy for resectable early-stage non-small-cell lung cancer (NSCLC).
According to the Committee for Medicinal Products for Human Use, the third-generation EGFR–tyrosine kinase inhibitor is indicated for patients with completely resected stage IB–IIIA NSCLC harboring EGFR exon 19 deletions or exon 21 L858R substitution mutations.
This adds to the previous positive decisions for osimertinib in the locally advanced or metastatic setting, which allow for the second- or later-line treatment of EGFR T790M mutation-positive NSCLC and the first-line treatment of NSCLC with activating EGFR mutations.
Osimertinib was approved for use in the early-stage, adjuvant setting by the FDA in December 2020.
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