Patients with a particular form of lung cancer can now potentially access a new second-line treatment option after European regulators issued a green light for Boehringer Ingelheim’s Vargatef (nintedanib).
The European Commission has approved use of the drug, alongside the chemotherapy docetaxel, in adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology, after first-line chemotherapy.
Adenocarcinoma is the most common type of lung cancer and the majority of patients are diagnosed in an advanced stage. Most will experience disease progression during or after first-line chemotherapy, and there is a significant unmet need for new, effective second-line options, the German drugmaker noted.
Vargatef is a triple angiokinase inhibitor taken twice daily in oral form. Clinical trials showed that adding the drug to docetaxel extended median overall survival from 10.3 to 12.6 months, with a quarter of patients surviving for two years or more (25.7% versus 19.1% for placebo/docetaxel).
A manageable adverse event profile that did not compromise overall health-related quality of life was also demonstrated, and discontinuation rates were not significantly increased in the Vargatef group, BI said.
The drug is the second to make it to market in BI’s oncology portfolio, following in the footsteps of Giotrif (afatinib) which has been approved in a different lung cancer setting. Nintedanib has also been cleared in the US for the lung-scarring condition idiopathic pulmonary fibrosis, and recently won backing from advisors to the European Medicines Agency.