EU approves Vargatef with docetaxel for NSCLC-Boehringer

The European Commission has granted EU marketing authorisation in 28 countries for Vargatef (nintedanib), from Boehringer, in combination with docetaxel for use in adult patients with locally advanced, metastatic or locally recurrent Non-Small Cell Lung Cancer (NSCLC) of adenocarcinoma tumour histology, after first-line chemotherapy. The approval is based on the outcomes of the LUME-Lung 1 clinical trial which enrolled 1,314 patients with NSCLC, after first-line chemotherapy. Data from the study, published in Lancet Oncology, demonstrated that compared to docetaxel alone, nintedanib when added to docetaxel significantly extended median overall survival from 10.3 to 12.6 months for patients with adenocarcinoma, with a quarter of patients surviving for two years or more (survival at 24 months – nintedanib plus docetaxel, 25.7% of patients vs. placebo plus docetaxel, 19.1% of patients).

Nintedanib demonstrated a manageable adverse event profile without further compromising patients’ overall health-related quality of life. Adding nintedanib to docetaxel did not significantly increase discontinuation rates, compared to docetaxel alone.