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www.fdanews.com/articles/176187-boehringer-nabs-extra-indication-for-giotrif-in-eu

Boehringer Nabs Extra Indication for Giotrif in EU

April 13, 2016

The European Commission has given the green light to Boehringer Ingelheim’s Giotrif for the treatment of advanced squamous cell lung cancer.

Giotrif — which already is approved for the treatment of EGFR mutation-positive non-small cell lung cancer in the EU — met its primary endpoint in a Phase 3 trial of reducing the risk of cancer progression by 19 percent. It also reduced the risk of death by 19 percent.

The drug is approved in more than 60 countries — including the U.S. — for the first-line treatment of EGFR mutation-positive NSCLC.