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05-03-2021 | FDA | News

approvalsWatch

Lorlatinib gains first-line NSCLC indication in USA

Author:
Shreeya Nanda

medwireNews: Lorlatinib can now be used for the frontline treatment of individuals with metastatic non-small-cell lung cancer (NSCLC) harboring ALK translocations, says the US FDA.

The regulatory body has also approved a companion diagnostic assay – the Ventana ALK (D5F3) CDx Assay (Ventana Medical Systems, Inc, Oro Valley, Arizona, USA) – to detect the presence of ALK alterations.

The ALK inhibitor was previously approved in the second- and third-line setting, with the current decision following the results of the phase 3 CROWN trial showing significantly improved progression-free survival with lorlatinib versus crizotinib in previously untreated patients.

As per the prescribing information, lorlatinib should be given orally at a dose of 100 mg/day.

medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2021 Springer Healthcare Ltd, part of the Springer Nature Group

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