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FDA Grants Priority Review to Afatinib for NSCLC With Rare EGFR Mutations

Jason Harris
Published: Tuesday, Oct 10, 2017

Martina Flammer, MD

Martina Flammer, MD
The FDA has granted a priority review to a supplemental new drug application (sNDA) for afatinib (Gilotrif) for the frontline treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors harbor EGFR exon 21 (L861Q), G719X, or S768I substitution mutations.

At the time of the analysis, 71 patients (95%) of patients assigned to afatinib had discontinued treatment, 48 of whom had initiated other systemic anticancer treatments. Across all subsequent lines of treatment, 59% patients received chemotherapy and 20% received an EGFR TKI. Of the 17 patients who received subsequent treatments in the chemotherapy group, 48% were given an EGFR TKI and 32% were given additional chemotherapy.
Yang JC-H, Sequist LV, Geater SL, et al. Clinical activity of afatinib in patients with advanced non-small-cell lung cancer harboring uncommon EGFR mutations: a combined post-hoc analysis of LUX-Lung 2, LUX-Lung 3, and LUX-Lung 6. Lancet Oncol. 2015;16(7):830-838. S1470-2045(15)00026-1.

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