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FDA approves Gilotrif for advanced squamous cell carcinoma of the lung
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The FDA today expanded the approval of afatinib to include the second-line treatment of patients with advanced squamous cell carcinoma of the lung that progressed after treatment with platinum-based chemotherapy, according to a press release from the drug’s manufacturer.
Afatinib (Gilotrif, Boehringer Ingelheim) also is indicated for the first-line treatment of specific types of EGFR mutation-positive non–small cell lung cancer.
The current approval is based in part on data from the LUX-Lung-8 trial, which included 795 patients with advanced squamous cell carcinoma of the lung, the second most prevalent subtype of NSCLC. Researchers randomly assigned patients to receive afatinib or erlotinib (Tarceva, Genentech, Astellas).
Results showed afatinib reduced the risk for progression by 18% and reduced the risk for death by 19%.
Further, significantly more patients assigned afatinib achieved disease control (51% vs. 40%; P = .002)
The most common adverse reactions observed in patients treated with afatinib included diarrhea (75%), rash or acne (70%), stomatitis (30%), decreased appetite (25%) and nausea (21%).
“We are pleased to bring a proven therapy to patients suffering from advanced squamous cell carcinoma of the lung who have progressed despite chemotherapy,” Sabine Luik, MD, senior vice president of medicine and regulatory affairs at Boehringer Ingelheim Pharmaceuticals. “This approval is further evidence of Boehringer Ingelheim’s strong commitment to bringing new treatment options to the lung cancer community.”