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National Institute for Health and Care Excellence ( NICE ) in the UK, has recommended Vargatef ( Nintedanib ) in combination with Docetaxel for use within the National Health Service ( NHS ) in England and Wales for patients with locally advanced metastatic or locally recurrent non-small cell lung cancer ( NSCLC ) of adenocarcinoma histology after first-line chemotherapy..

NICE determination is based on the outcomes of the LUME-Lung 1 study which has demonstrated:

Nintedanib plus Docetaxel significantly prolonged progression-free survival compared to Docetaxel alone for patients with adenocarcinoma ( progression-free survival: primary endpoint; 4.0 vs 2.8 months );

Nintedanib plus Docetaxel, significantly extended overall survival to beyond one year for patients with adenocarcinoma, compared to Docetaxel alone ( overall survival: key secondary endpoint; 12.6 vs 10.3 months );

Nintedanib plus Docetaxel, enabled 1 in 4 patients with adenocarcinoma to live for at least two years after first-line chemotherapy.

Nintedanib in combination with Docetaxel has demonstrated a generally manageable side-effect profile without further compromising patients’overall, health-related, quality of life compared to chemotherapy alone.
The most common adverse events for patients taking Docetaxel vs Nintedanib plus Docetaxel included: nausea 18% vs 24%; vomiting 9% vs 17%; diarrhoea 22% vs 42% and elevated liver enzymes 8% vs 29%.

Adenocarcinoma is the most common type of lung cancer and the majority of patients are diagnosed in an advanced stage. Most patients will experience disease progression during or after first-line chemotherapy and there is a significant need for new, effective second-line treatments.

Nintedanib is an oral triple angiokinase inhibitor which simultaneously inhibits vascular endothelial growth factor receptors ( VEGFR ), platelet-derived growth factor receptors ( PDGFR ) and fibroblast growth factor receptors ( FGFR ) signalling pathways.
Growing scientific evidence has shown that these three different angiokinase receptors play an important role not only in angiogenesis but also in tumour growth and metastasis. ( Xagena )

Source: Boehringer Ingelheim, 2015

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