FDA approves sNDA for Giotrif (afatinib) in advanced squamous cell carcinoma of the lung- Boehringer

The FDA has approved a supplemental New Drug Application (sNDA) for Giotrif (afatinib) tablets, from Boehringer, for the treatment of patients with advanced squamous cell carcinoma of the lung whose disease has progressed after treatment with platinum-based chemotherapy. The U.S. approval follows the recent marketing authorization of Giotrif in this patient population by the European Commission. Giotrif, an oral, once-daily EGFR-directed therapy, is currently approved in the U.S. for the first-line treatment of specific types of EGFR mutation-positive NSCLC.

The sNDA was based on results of the head-to-head LUX-Lung 8 trial in patients with SqCC of the lung whose tumors progressed after first-line chemotherapy. Giotrif, compared to erlotinib, demonstrated a significant delay in progression of lung cancer (PFS, progression-free survival, primary endpoint), reducing the risk of cancer progression by 18%. In addition, it showed a significant improvement in overall survival (OS, key secondary endpoint), reducing the risk of death by 19%, along with significantly improved disease control rate (51% vs 40%). The most common adverse reactions observed with Giotrif (reported in at least 20% of study patients) were diarrhea (75%), rash or acne (70%), stomatitis (mouth sores) (30%), decreased appetite (25%), and nausea (21%).

Comment: Squamous cell carcinoma (SqCC) of the lung is associated with a poor prognosis, limited survival and symptoms like cough and dyspnea. The median overall survival (OS) after diagnosis of advanced SqCC is around one year.