FDA expands use of lung cancer drug Gilotrif

The Food and Drug Administration has granted approval to afatinib (US brand name Gilotrif) for a broadened indication in first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test.

German family-owned Boehringer Ingelheim’s afatinib, sold outside the USA under the trade name Giotrif, is approved in over 70 countries for the first-line treatment of EGFR mutation-positive NSCLC.

The latest FDA approval was based on demonstration of durable responses in a subset of 32 afatinib-treated patients with metastatic NSCLC harboring non-resistant EGFR mutations (S768I, L861Q, and/or G719X) other than exon 19 deletions or exon 21 L858R substitutions enrolled in one of three clinical trials (LUX-Lung 2 [NCT00525148], LUX-Lung 3 [NCT00949650], and LUX-Lung 6 [NCT01121393]).