EU green lights BI's Vargatef for advanced lung cancer
- The European Medicines Agency (EMA) has approved Boehringer Ingelheim's Vargatef (nintedanib) for treatment of advanced lung cancer patients with adenocarcinoma after first-line chemotherapy.
- In phase III trials, treatment with Vargatef (when added to docetaxel) resulted in median overall survival of 12.6 months in advanced lung cancer patients (versus 10.3 months for docetaxel alone).
- More than 1,300 patients in 27 countries were tested with Vargatef. The approval is valid for all countries in the EU.
Lung cancer is the most common cancer worldwide and is especially deadly, with only a 17.8% five-year survival rate. In addition, most patients are diagnosed at late stages of the disease.
According to information provided on the Boehringer Ingelheim, Vargatef is an oral triple angiokinase inhibitor which simultaneously inhibits vascular endothelial growth factor receptors (VEGFR), platelet-derived growth factor receptors (PDGFR), and fibroblast growth factor receptors (FGFR) signaling pathways. Growing scientific evidence shows that these three different angiokinase receptors play an important role, not only in angiogenesis, but also in tumor growth and metastasis.
Vargatef's approval comes on the heels of an approval for another BI lung cancer drug, Giotrif (afatinib), which is indicated for the treatment of EGRF-mutation positive NSCLC.