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Boehringer’s Vargatef approved in the EU for lung cancer

Marks company’s second oncology drug to hit market
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Boehringer Ingelheim continued to build its oncology ambitions with European approval for a second lung cancer drug.

The European Commission granted marketing authorisation for Vargatef (nintedanib) in combination with docetaxal for use in adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) after first-line chemotherapy.

Prof Klaus Dugi, Boehringer's chief medical officer, said: “The approval of Vargatef expands our oncology portfolio, following last year's approval of Giotrif (afatinib) for another specific type of lung cancer.”

The launch of Giotrif/Gilotrif in 2013 as a treatment lung cancer patients who express epidermal growth factor receptor (EGFR) marked Boehringer's entry onto the oncology market.

The addition of Vargatef widens the potential patient base for the German company, allowing Boehringer to make sizeable inroads into lung cancer.

Vargatef, a triple angiokinase inhibitor, has impressed in clinical trials, including the LUME-Lung 1 clinical trial involving 1,314 patients with NSCLC.

The drug demonstrated that, compared to docetaxel alone, Vargatef extended median survival from 10.3 months to 12.6 months, with a 25.7% surviving for two years or more.

Nintedanib has also shown potential outside of cancer, recently being recommended for EU approval as a treatment for the rare lung condition idiopathic pulmonary fibrosis (IPF). The drug received US approval in this indication in October under the name Ofev.

Article by
Kirstie Pickering

28th November 2014

From: Sales



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