“US health officials have expanded the approved indications for Boehringer Ingelheim’s Gilotrif, clearing its use in patients with squamous cell carcinoma of the lung.
“Gilotrif (afatinib), an oral, once-daily EGFR-directed therapy, is currently cleared in the US for the first-line treatment of specific types of EGFR mutation-positive non-small cell lung cancer.
“Approval for squamous cell carcinoma of the lung, a disease linked with a particularly bleak poor prognosis of one-year survival post diagnosis, was based on data from the head-to-head LUX-Lung 8 trial in patients whose tumours progressed after first-line chemotherapy.”
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“In the phase III LUX-Lung 8 trial reported in The Lancet Oncology, Soria et al found that the irreversible ErbB-family inhibitor afatinib (Gilotrif) significantly improved progression-free and overall survival vs the EGFR tyrosine kinase inhibitor erlotinib as second-line treatment in patients with stage IIIB or IV squamous cell carcinoma of the lung who had disease progression after four or more cycles of platinum-based chemotherapy.
“In this open-label trial, 795 patients from 23 countries were randomly assigned between March 2012 and January 2014 to receive afatinib at 40 mg/d (n =398) or erlotinib at 150 mg/d (n = 397). The primary endpoint was progression-free survival on independent central review in the intent-to-treat population…
“The investigators concluded: ‘The significant improvements in progression-free survival and overall survival with afatinib compared with erlotinib, along with a manageable safety profile and the convenience of oral administration suggest that afatinib could be an additional option for the treatment of patients with squamous cell carcinoma of the lung.’ “
“Boehringer Ingelheim’s Giotrif has shown a greater survival benefit than Roche’s Tarceva in previously-treated patients with advanced squamous cell carcinoma of the lung.
“According to data from the LUX-Lung 8 trial, published in The Lancet Oncology, Giotrif (afatinib) extended overall survival to a median of 7.9 months compared to 6.8 months on Tarceva (erlotinib), reducing the risk of death by 19%.
“The study also met its primary endpoint showing a significant improvement in progression-free survival over Tarceva, which is an approved and recommended treatment option for advanced SCC of the lung following treatment with first-line platinum-based chemotherapy.”