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24-05-2021 | Non-small-cell lung cancer | Adis Journal Club | Article

Drugs

Lazertinib: First Approval

Authors: Sohita Dhillon

Abstract

Lazertinib (LECLAZA®) is an oral, third-generation, epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) being developed by Yuhan and Janssen Biotech for the treatment of non-small cell lung cancer (NSCLC). It is a brain-penetrant, irreversible EGFR-TKI that targets the T790M mutation and activating EGFR mutations Ex19del and L858R, while sparing wild type-EGFR. In January 2021, lazertinib received its first approval for the treatment of patients with EGFR T790M mutation-positive locally advanced or metastatic NSCLC who have previously received EGFR-TKI therapy. This article summarizes the milestones in the development of lazertinib leading to this first approval.

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Lazertinib (LECLAZA®): Key Points

An oral EGFR-TKI being developed by Yuhan and Janssen Biotech for the treatment of NSCLC

Received its first approval on 18 January 2021 in the Republic of Korea

Approved for the treatment of patients with EGFR T790M mutation-positive locally advanced or metastatic NSCLC who have previously received EGFR-TKI therapy

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