FDA approves Boehringer's Gilotrif for new indication

16 April 2016

The US subsidiary of German family-owned pharma major Boehringer Ingelheim said on Friday that the US Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for its lung cancer therapy Gilotrif (afatinib) for the second-line treatment of patients with advanced squamous cell carcinoma of the lung.

Squamous cell carcinoma (SqCC) of the lung is the second largest sub-type of non-small cell lung cancer (NSCLC) and represents approximately 20%-30% of all NSCLC cases. It is associated with a poor prognosis, limited survival and symptoms like cough and dyspnea, and the median overall survival (OS) after diagnosis is around one year.

Follows similar approval in Europe

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