The European Union (EU) approved Giotrif (afatinib) on April 8 for the treatment of advanced squamous cell carcinoma (SqCC) of the lung in people for whom the disease has progressed despite treatment with platinum-based chemotherapy. This will allow marketing and sale of the medication in 28 countries in the EU.
Symptoms of SqCC include cough and extreme difficulty breathing. Outcomes for SqCC are extremely poor. Additional treatments for the disease are therefore greatly needed.
Afatinib has previously received approval, in more than 60 countries, for the initial treatment of EGFR mutation-positive non-small cell lung cancer (NSCLC).
“Whilst there have been some recent and significant advances in the treatment of squamous cell carcinoma of the lung, the intravenous administration and frequent visits to the hospital can be a challenge for patients often debilitated by this disease,” said Dr. Mehdi Shahidi, medical head, Solid Tumor Oncology at Boehringer Ingelheim, in a press release. “In this context and supported by robust evidence from a global head-to-head Phase 3 study, we are pleased to offer an effective oral treatment option for patients suffering from this type of lung cancer to the European market.”
The EU commission based their approval on results from the LUX-Lung 8 clinical trial. According to the press release from Boehringer Ingelheim, the study results demonstrated:
- “Significant delay in progression of lung cancer (PFS, progression-free survival, primary endpoint), reducing the risk of cancer progression by 19 percent;
- Significant improvement in overall survival (OS, key secondary endpoint), reducing the risk of death by 19 percent;
- Significantly improved disease control rate (51 percent vs. 40 percent; P=0.002)
- An improvement in quality of life and control of cancer symptoms.
Detailed results from the LUX-Lung 8 clinical trial appeared in the journal The Lancet Oncology. The trial compared the medication erlotinib to afatinib. Overall, afatinib was associated with better survival than erlotinib. Side effects were similar between the two medications, with more frequent severe diarrhea and mouth sores with afatinib compared to erlotinib, and more frequent severe rash or acne with erlotinib.
Afatinib can be administered orally, which can be a more convenient option for patients.