The approval is for nintedanib (Vargatef) in combination with docetaxel to treat adults with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumor histology after first-line chemotherapy.
The positive opinion from CHMP is based on the results of the LUME-Lung 1 clinical trial, which showed that compared to docetaxel alone, nintedanib plus docetaxel significantly extended the median overall survival from 10.3 to 12.6 months for patients with advanced adenocarcinoma, after first-line chemotherapy.
Adenocarcinoma is the most common type of lung cancer and these patients will experience disease progression after first-line chemotherapy and there is still a significant unmet need for new, effective second-line treatments for them who have a poor prognosis.
Boehringer Ingelheim chief medical officer Dr Klaus Dugi said: "Nintedanib, a triple angiokinase inhibitor, when added to docetaxel, provided adenocarcinoma patients with a median overall survival of over one year, a benefit which has not been achieved before."
In the randomised, double-blind LUME-Lung 1 Phase III trial a total of 1,314 patients, in Europe, Asia and South Africa, were given nintedanib 200mg twice daily plus docetaxel 75mg/m2 once a day, for three weeks or placebo plus docetaxel.
The trial compared nintedanib plus docetaxel in patients with locally advanced/metastatic NSCLC after first-line therapy, with placebo plus docetaxel.
The most common adverse events (AEs) observed in patients taking nintedanib plus docetaxel were gastro-intestinal side effects and reversible liver enzyme elevations which were manageable by either supportive treatment or dose reduction.
Image: Boehringer Ingelheim Center (BIC), the Corporate Headquarters Building in Ingelheim, Germany. Photo: courtesyofBoehringer Ingelheim GmbH.