FDA Approves New Indication for Gilotrif

The FDA granted a new indication to afatinib (Gilotrif, Boehringer Ingelheim) for the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have nonresistant epidermal growth factor receptor (EGFR) gene mutations, as determined by an approved test.

Afatinib was previously approved for the treatment of patients with advanced lung squamous cell carcinoma whose disease progressed after treatment with platinum-based chemotherapy.

The new indication is based on data