Afatinib (Gilotrif) shows significant improvements in overall survival and disease progression.
On Friday, the FDA approved a new oral drug, afatinib (Gilotrif), for the treatment of advanced squamous cell carcinoma (SqCC) of the lung in patients who have progressed after receiving chemotherapy.
The approval was based on the results of the head-to-head LUX-Lung 8 clinical trial that compared Gilotrif to erlotinib (Tarceva) in patients with advanced SqCC of the lung, a disease that has a median overall survival (OS) of about 1 year after diagnosis.
The results of the study showed a significant reduction in the risk of cancer progression of 18%. The OS also had significant improvement and reduced the risk of death by 19%. Lastly, the disease control rate improved 51% in the Gilotrif group compared with 40% in the Tarceva group (P=0.002).
“The overall survival data and significant delay in lung cancer progression seen in the global head-to-head phase 3 trial demonstrated that Gilotrif is an effective new treatment option in this patient population,” said investigator Shirish Gadgeel, MD.
The most common adverse events that affected at least 20% of participants included diarrhea, rash or acne, stomatitis, decreased appetite, and nausea.
“We are pleased to bring a proven therapy to patients suffering from advanced squamous cell carcinoma of the lung who have progressed despite chemotherapy,” said Sabine Luik, MD, senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “This approval is further evidence of Boehringer Ingelheim’s strong commitment to bringing new treatment options to the lung cancer community.”