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FDA Approves Gilotrif Lung Cancer Treatment for Squamous Cell Carcinoma of the Lung

Boehringer Ingelheim Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for its lung cancer therapy 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.

This approval follows the recent marketing authorization of this lung cancer treatment by the European Commission for the same patient population, and is based on results from the head-to-head LUX-Lung 8 trial evaluating patients with SqCC of the lung whose tumors progressed after first-line chemotherapy.

More information can be found in the press release online here.

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