FDA, EMA Accept Filings for BI Lung Cancer DrugBy
Boehringer Ingelheim reports that the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted filing applications for afatinib for the treatment of patients with advanced squamous cell carcinoma of the lung progressing after treatment with first-line chemotherapy. Afatinib has also been granted orphan drug designation by the FDA.
Afatinib, an oral, once daily EGFR-directed therapy, is currently approved in more than 60 countries for the first-line treatment of specific types of EGFR mutation-positive non small-cell lung cancer (under brand names: Giotrif/Gilotrif).
Source: Boehringer Ingelheim