Boehringer gets EU marketing approval for lung cancer drug Vargatef

Vargatef in combination with docetaxel is approved for use in adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumor histology, after first-line chemotherapy.

The approval of nintedanib is based on the data from the LUME-Lung I clinical trial which enrolled 1,314 patients with NSCLC, after first-line chemotherapy.

The results showed that compared to docetaxel alone, nintedanib when added to docetaxel significantly extended median overall survival from 10.3 to 12.6 months for patients with adenocarcinoma, with a quarter of patients surviving for two years or more.

Lung Clinic Grosshansdorf head of Department of Thoracic Oncology and lead investigator of the LUME-Lung I trial Dr Martin Reck said: "The approval of nintedanib offers a much needed new treatment option for adult lung cancer patients with advanced adenocarcinoma in the second-line setting.

"The clinical data has shown that patients receiving nintedanib plus docetaxel experienced over one year overall survival with no further compromise to their quality of life, compared to docetaxel alone."

Adenocarcinoma is the most common type of lung cancer and majority of patients are diagnosed in an advanced stage.

Boehringer Ingelheim chief medical officer professor Klaus Dugi 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 US FDA."

Nintedanib, an oral, twice-daily treatment, is the second approved compound in the the company’s oncology portfolio, while Giotrif was the first to be approved to treat NSCLS patients with distinct types of EGFR-mutation positive NSCLC.

Image: Boehringer Ingelheim’s corporate headquarters in Ingelheim, Germany. Photo: courtesy of Boehringer Ingelheim GmbH.