European Commission Grants Boehringer’s Vargatef Regulatory Approval
Boehringher Ingelheim announced yesterday that the European Commission has granted marketing authorisation for their Vargatef (nintedanib). Vargatef is a triple angiokinase inhibitor for the treatment of lung cancer patients.
The drug has been approved when used in combination with docetaxel for adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumor histology, after first-line chemotherapy.
The regulatory approval is based around the data from the LUME-Lung I clinical trial which enrolled 1,314 patients.
The results of the clinical trial highlighted that compared to docetaxel alone, when combining docetaxel with nintedanib it significantly extended median overall survival from 10.3 to 12.6 months, with a quarter of patients surviving for two or more years.
Dr Martin Reck, Lung Clinic Grosshansdorf head of Department of Thoracic Oncology and lead investigator of the LUME-Lung I trial, commented that the regulatory approval “offers a much needed new treatment option for adult lung cancer patients with advanced adenocarcinoma in the second-line setting.”
The drug, an oral, twice-daily treatment, is the second approved compound in Boehringer Ingelheim’s oncology portfolio.