25 August 2015 - Boehringer Ingelheim today announced that both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted filing applications for afatinib dimaleate for the treatment of patients with advanced SCC of the lung progressing after treatment with first-line chemotherapy. Afatinib has also been granted orphan drug designation by the FDA – a status given to a product intended for the treatment of a rare disease or condition.

Dr. Jörg Barth, Corporate Senior Vice President, Therapy Area Head Oncology, Boehringer Ingelheim commented: “Working with the US and EU regulatory authorities marks the next stage in our journey to hopefully provide patients with a new, oral treatment for squamous cell carcinoma of the lung, a condition with an extremely poor prognosis and still limited treatment options. This is an encouraging prospect for Boehringer Ingelheim as we remain fully dedicated to improving and extending the lives of patients with different types of lung cancer.”

The submissions are based on data from the Phase III LUX-Lung 8 trial that compared Giotrif / Gilotrif (afatinib dimaleate) to Tarceva (erlotinib hydrochloride) 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 hydrochloride in this patient population.

For more details, go to: https://www.boehringer-ingelheim.com/news/news_releases/press_releases/2015/25_august_2015_oncology.html