FDA and EMA accept regulatory applications for Boehringer's Giotrif/Gilotrif for advanced SCC of the lung

The US Food and Drug Administration and the European Medicines Agency have accepted filing applications for afatinib for the treatment of patients with advanced squamous cell carcinoma (SCC) of the lung progressing after treatment with first-line chemotherapy.

Afatinib, marketed under the trade names Giotrif and Gilotrif, 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, says the drug’s maker German family-owned pharma major Boehringer Ingelheim. The drug is already approved for patients with metastatic non-small cell lung cancer (NSCLC).

Jörg Barth, corporate senior vice president, therapy area head Oncology, at 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.”