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Drugs
Erschienen in: Drugs 2/2016

01.02.2016 | AdisInsight Report

Osimertinib: First Global Approval

verfasst von: Sarah L. Greig

Erschienen in: Drugs | Ausgabe 2/2016

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Abstract

Osimertinib (Tagrisso™, AZD9291) is an oral, third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) that is being developed by AstraZeneca for the treatment of advanced non-small cell lung cancer (NSCLC). Osimertinib has been designed to target the EGFR T790M mutation that is often present in NSCLC patients with acquired EGFR TKI resistance, while sparing wild-type EGFR. In November 2015, the tablet formulation of osimertinib was granted accelerated approval in the USA for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC (as detected by an FDA-approved test) who have progressed on or after EGFR TKI therapy. Osimertinib has also been granted accelerated assessment status for this indication in the EU, and is in phase III development for first- and second-line and adjuvant treatment of advanced EGFR mutation-positive NSCLC in several countries. Phase I trials in patients with advanced solid tumours are also being conducted. This article summarizes the milestones in the development of osimertinib leading to this first approval for NSCLC.
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Metadaten
Titel
Osimertinib: First Global Approval
verfasst von
Sarah L. Greig
Publikationsdatum
01.02.2016
Verlag
Springer International Publishing
Erschienen in
Drugs / Ausgabe 2/2016
Print ISSN: 0012-6667
Elektronische ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-015-0533-4

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