Posted by Michael Wonder on 25 Sep 2024
FDA approves osimertinib for locally advanced, unresectable (stage III) non-small cell lung cancer following chemoradiation therapy
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.
