US health officials have expanded the approved indications for Boehringer Ingelheim’s Gilotrif, clearing its use in patients with squamous cell carcinoma of the lung.
Gilotrif (afatinib), an oral, once-daily EGFR-directed therapy, is currently cleared in the US for the first-line treatment of specific types of EGFR mutation-positive non-small cell lung cancer.
Approval for squamous cell carcinoma of the lung, a disease linked with a particularly bleak poor prognosis of one-year survival post diagnosis, was based on data from the head-to-head LUX-Lung 8 trial in patients whose tumours progressed after first-line chemotherapy.
Compared to Roche/Astellas’ Tarceva (erlotinib), Gilotrif showed significant: delay in the progression of lung cancer, reducing the risk by 18%; improvement in overall survival, reducing the risk of death by 19%; and improvement in the disease control rate (51% vs 40%), Boehringer noted.
The US approval follows the recent marketing green light for this patient population in Europe, where the drug is marketed at Giotrif.