Boehringer Ingelheim submits lung cancer treatment, Nintedanib, for approval in the EU

October 14 ,2013 | By Márcio Barra

Nintedanib (trade name Vargatef) has been submitted for approval in Europe as a second-line treatment alongside docetaxel (a chemotherapy agent) for the treatment of locally advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) in patients whose tumours are adenocarcinomas – cancer developed from the cells that produce mucus in the lining of the airways – the most common type of lung cancer.

Nintedanib submission is backed up by the results of the LUME-Lung 1 trial, which enrolled 1.314 patients and 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 12.6 months for patients treated with Nintedanib.

In addition, the study showed that Nintedanib had an even superior overall survival extension (20%) compared to placebo in patients who failed first-line chemotherapy within nine months. Based on these results, Boehringer Ingelheim is touting Nintedanib as the first lung cancer treatment that has extended patient survival beyond one year in adenocarcinoma patients after initial chemotherapy has failed.

Nintedanib is a triple angiokinase inhibitor, meaning, it inhibits vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR) and platelet derived growth factor receptor (PDGFR). This in turn prevents the formation of new blood vessels around tumours (angiogenesis), limiting the tumour’s supply of blood.

If Nintedanib receives an approval from the European Medicines Agency (EMA), it will be Boehringer’s second NSCLC treatment in Europe after irreversible ErbB blocker Giotrif (afatinib), an irreversible ErbB blocker approved last month.The drug is also being currently investigated as a potential treatment for ovarian cancer, renal cell carcinoma, hepatic cell carcinoma and colorectal cancer.



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