The US Food and Drug Administration (FDA) granted Priority Review to afatinib as first-line treatment for patients with non–small cell lung cancer (NSCLC) positive for epidermal growth factor receptor (EGFR) exon 21 (L861Q), G719X, or S768I substitution mutations.1

These mutations are present in approximately 10% of patients with EGFR-positive NSCLC and are associated with significantly worse outcomes.

The FDA based its approval on findings from a meta-analysis of 3 trials from the LUX-Lung clinical trial program. A post-hoc analysis published in The Lancet Oncology presented data from the LUX-Lung 2, LUX-Lung 3, and LUX-Lung 6 studies, for which researchers prospectively analyzed data from 75 EGFR TKI–naive patients with uncommon EGFR-positive NSCLC.2

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Among patients with the point mutations or duplications in exons 18 to 21, 71.1% (21) treated with afatinib had an objective response (95% CI, 54.1%-84.6%). Median progression-free survival was 10.7 months (95% CI, 5.6-14.7), and median overall survival was 19.4 months (95% CI, 16.4-26.9).

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The FDA grants Priority Review to medications with the potential to significantly improve outcomes or safety in the treatment, diagnosis, or prevention of serious conditions compared with available treatments.


  1. FDA grants Priority Review to Gilotrif® for uncommon EGFR mutations in advanced NSCLC [news release]. Ridgefield, CT: Boehringer Ingelheim; October 10, 2017. Accessed October 10, 2017.
  2. Yang JC, Sequist LV, Geater SL, et al. Clinical activity of afatinib in patients with advanced non-small-cell lung cancer harbouring uncommon EGFR mutations: a combined post-hoc analysis of LUX-Lung 2, LUX-Lung 3, and LUX-Lung 6. Lancet Oncol. 2015;16(7):830-8.