CHMP recommends Vargatef + docetaxel for treatment of Non Small Cell Lung Cancer - Boehringer
Boehringer Ingelheim announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the approval of nintedanib (suggested brand name Vargatef) in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent Non-Small Cell Lung Cancer (NSCLC) of adenocarcinoma tumour histology after first-line chemotherapy.
The CHMP opinion is based on the outcomes of the LUME-Lung 1 clinical trial. The results 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 (p=0.0359; HR: 0.83). The additional benefit nintedanib provided to adenocarcinoma patients was achieved without nintedanib further impacting their quality of life.
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