Osimertinib: A Review in Previously Untreated, EGFR Mutation-Positive, Advanced NSCLC

<b>Declarations</b><br><br><b>Funding</b> The preparation of this review was not supported by any external funding.<br><br><b>Authorship and Conflict of interest</b> Yvette Lamb is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.<br><br><b>Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability</b> Not applicable<br><br>Additional information about this Adis Drug Review can be found <a href="http://www.springer.com/gp/adis/products-services/adis-journals-newsletters/adis-drug-reviews">here</a><br><br>Abstract<br><br><div>Activating mutations in the epidermal growth factor receptor (<i>EGFR</i>) gene have been identified as key oncogenic drivers of non-small cell lung cancer (NSCLC). Osimertinib (Tagrisso^®) is an orally administered, third-generation EGFR tyrosine kinase inhibitor (EGFR-TKI) that is widely approved for the first-line treatment of advanced NSCLC with activating <i>EGFR</i> mutations. In the pivotal phase III FLAURA trial, osimertinib significantly prolonged progression-free survival (PFS) and overall survival (OS) relative to first-generation EGFR-TKIs in patients with previously untreated, <i>EGFR</i> mutation-positive, advanced NSCLC. Osimertinib also significantly prolonged central nervous system (CNS) PFS in patients with CNS metastases at trial entry. Osimertinib had a generally manageable tolerability profile; the majority of adverse events considered to be possibly related to treatment were of mild to moderate severity. Osimertinib represents a valuable targeted therapeutic for use in adults with previously untreated, <i>EGFR</i> mutation-positive, advanced NSCLC.</div><div><br></div><div>A plain language summary slide is shown above.<br><br>© Springer Nature Switzerland AG 2021</div>