US FDA grants approval of osimertinib (Tagrisso) as first adjuvant treatment for early stage non-small cell lung cancer with specific genetic mutation

Approval was based on an RCT of 682 patients with stage IB to IIIA EGFR exon 19 deletions or exon 21 L858R mutation–positive cancer, which reported longer disease-free survival at 24 months with osimertinib vs placebo (90% vs 44%; HR, 0.17; 99% CI, 0.11 to 0.26; P<0.001).

Source:

FDA