Drug maker Boehringer Ingelheim has announced that the European Commission granted Vargatef® (nintedanib) marketing approval in 28 EU countries. Together with docetaxel, it is indicated for the post-chemotherapy treatment of either locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumor histology, which is the most commonly diagnosed type of tumor in the lungs. Most patients only receive their diagnoses in early stages of the disease, and will experience cancer progression during or after chemotherapy. This underscores the need for a reliable second-line treatment.
According to Dr. Martin Reck, Head of Department of Thoracic Oncology, Lung Clinic Grosshansdorf, Germany and head researcher of the LUME-Lung 1 trial, Vargatef®’s performance with docetaxel in clinical studies allowed patients more than 1 year of survival without reduction in quality of life, compared to monotreatment with docetaxel after first-line chemotherapy.
The Commission’s approval was based on the findings from the LUME-Lung 1 clinical trial, which involved 1,314 NSCLC patients who had undergone first-line chemotherapy. Nintedanib administered with docetaxel considerably extended average overall survival from 10.3 to 12.6 months, with about 25% of the participants surviving at least 2 years. It also showed an optimistic adverse event profile compared to treatment with docetaxel alone.
Professor Klaus Dugi, the Chief Medical Officer of Boehringer Ingelheim, said, “The approval of Vargatef® expands our oncology portfolio, following last year’s approval of GIOTRIF® (afatinib) for another specific type of lung cancer. In the idiopathic pulmonary fibrosis indication, nintedanib has recently been approved by the U.S. FDA.”
Vargatef® (nintedanib) is an oral, twice-a-day treatment for NSCLC of adenocarcinoma tumor histology, and is the second drug in Boehringer’s cancer portfolio to receive EU authorization. The first Boehringer NSCLC treatment to receive approval was GIOTRIF® (afatinib). Nintedanib is also marketed by the Boehringer Ingelheim as a novel treatment for idiopathic pulmonary fibrosis. Just recently, the drug received endorsement from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based on results from the Phase III INPULSIS® trials entitled “Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis” were published in the New England Journal of Medicine.