Boehringer Ingelheim has submitted a marketing authorisation application to the European Medicines Agency (EMA) for the approval of its oral triple angiokinase inhibitor nintedanib.
Nintedanib to be used in combination with docetaxel is intended for treating patients with locally advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology.
According to the company, nintedanib is claimed to be the first lung cancer treatment that extended patient survival beyond one year in a broad population of adenocarcinoma patients, after failure of initial chemotherapy.
Boehringer Ingelheim corporate senior vice president Medicine Klaus Dugi said nintedanib is a compound out of the company's new oncology research programme and is the second compound in its portfolio to be filed with the EMA.
"Improving patients' lives remains at the forefront of Boehringer Ingelheim's commitment to evidence based progress in the treatment of cancer," Dugi added.
Adenocarcinoma is the most common type of lung cancer with over two-thirds of patients diagnosed at a late stage when curative treatment is no longer possible and all patients will progress and require second-line treatment.
The EU marketing authorization application is based on the results from the international, double-blind, Phase III LUME-Lung 1 trial which compared nintedanib plus docetaxel to docetaxel and placebo.
The results showed that the patients in the placebo arm had an increase in median overall survival of 10.3 months after patients failed first-line chemotherapy compared to an increase of 12.6 months with nintedanib.
