publication date: Apr. 25, 2016

Drugs and Targets

FDA Approves Gilotrif Tablets for Squamous Cell Lung Cancer 


FDA approved Gilotrif (afatinib) tablets for the treatment of patients with advanced squamous cell carcinoma of the lung whose disease has progressed after treatment with platinum-based chemotherapy.

The U.S. approval follows the recent marketing authorization of Gilotrif in this patient population by the European Commission. Gilotrif, an oral, once-daily EGFR-directed therapy developed by Boehringer Ingelheim, is currently approved in the U.S. for the first-line treatment of specific types of EGFR mutation-positive NSCLC.

The sNDA was based on results of the head-to-head LUX-Lung 8 trial in patients with SqCC of the lung whose tumors progressed after first-line chemotherapy. Gilotrif, compared to erlotinib, demonstrated: significant delay in progression of lung cancer, reducing the risk of cancer progression by 18 percent; significant improvement in overall survival, reducing the risk of death by 19 percent; and a significantly improved disease control rate, at 51 vs 40 percent (p=0.002).

The most common adverse reactions observed with Gilotrif were diarrhea, rash or acne, stomatitis, decreased appetite, and nausea.


The University of Chicago and AbbVie entered into a five-year collaboration in oncology.

Initially, both organizations will work together to advance research in several areas of oncology, which could include, among others, breast, lung, prostate, colorectal and hematological cancer. Research projects are chosen by a joint steering committee, comprised of representatives from each organization. AbbVie also gains an option for an exclusive license … Continue reading 42-16 FDA Approves Gilotrif Tablets for Squamous Cell Lung Cancer

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