FDA approves osimertinib for locally advanced, unresectable (stage III) non-small cell lung cancer following chemoradiation therapy

FDA

25 September 2024 - Today, the FDA approved osimertinib (Tagrisso, AstraZeneca Pharmaceuticals) for adult patients with locally advanced, unresectable (stage III) non-small cell lung cancer whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumours have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.

Efficacy was evaluated in LAURA, a double blind, randomised, placebo-controlled trial in 216 adult patients with locally advanced, unresectable stage III non-small cell lung cancer with EGFR exon 19 deletions or exon 21 L858R mutations who had not progressed during or following definitive platinum-based chemoradiation within 42 days prior to study randomisation.

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Michael Wonder

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Michael Wonder

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Cancer , Outcome , Medicine , US