FDA Approves New Indication for Gilotrif

By Marie Rosenthal

The FDA granted a new indication for oral 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. The mutations must be detected using an FDA-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