FDA Approves Afatinib for Platinum-refractory Advanced Squamous NSCLC
The FDA has approved afatinib for the treatment of patients with advanced squamous cell carcinoma of the lung.
The U.S. Food and Drug Administration (FDA) has approved afatinib for the treatment of patients with advanced squamous cell carcinoma of the lung whose disease has progressed following platinum-based chemotherapy.1
“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.”
Approval of this supplemental New Drug Application was based on findings from the LUX-Lung 8 trial, which evaluated the safety and efficacy of afatinib with that of erlotinib in 795 patients with metastatic squamous non-small cell lung cancer (NSCLC) whose tumors progressed after first-line chemotherapy.
Results showed that afatinib significantly reduced the risk of disease progression by 18% and significantly reduced by the risk of death by 19% vs erlotinib. Afatinib was also associated with a significant improvement in disease control rate (51% vs 40%; P = .002).
In regard to safety, the most common adverse events with afatinib were diarrhea (75%), rash/acne (70%), stomatitis (30%), decreased appetite (25%), and nausea (21%).
Clinicians should be advised that severe diarrhea, bullous and exfoliative skin disorders, interstitial lung disease, hepatotoxicity, and keratitis may occur.
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Afatinib is a kinase inhibitor initially approved by the FDA in 2013 for the first-line treatment of patients with metastatic NSCLC whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 substitution mutations.
The recommended dose and schedule of afatinib for both indications is 40 mg orally once daily taken at least 1 hour before or 2 hours after meals.
- Gilotrif (afatinib) [prescribing information]. Ridgefield, CT: Boehringer Ingelheim; April 15, 2016. http://docs.boehringer-ingelheim.com/Prescribing%20Information/PIs/Gilotrif/Gilotrif.pdf.