Giotrif/Gilotrif (afatinib) filed with FDA and EMA for advanced squamous cell carcinoma of lung- Boehringer Ingelheim

The FDA and the European Medicines Agency (EMA) have accepted filing applications for Giotrif/Gilotrif (afatinib), from Boehringer Ingelheim, for the treatment of patients with advanced squamous cell carcinoma (SCC) of the lung, a subset of non small cell lung cancer, progressing after treatment with first-line chemotherapy. Afatinib has also been granted orphan drug designation by the FDA.

The submissions are based on data from the Phase III LUX-Lung 8 trial that compared afatinib to erlotinib (Tarceva) in patients with advanced SCC of the lung progressing after treatment with first-line platinum-based chemotherapy. Data from the trial showed that treatment with afatinib resulted in superior progression-free survival (PFS, primary endpoint), reducing the risk of cancer progression by 19%, and superior overall survival (OS, key secondary endpoint), reducing the risk of death by 19% compared to erlotinib in this patient population.

Comment: Afatinib was approved for NSCLC in the US and EU in 2013. Tarceva from Roche and Astellas (US) will be a formidable competitor, approved for first line metaststic NSCLC with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and a diagnostic test. By 2013 Tarceva had captured most of the US EGFR inhibitor market. On available data, afatinib does not look more efficacious than erlotinib and is also associated with more side effects.