EU Approves BI’s Lung Cancer Drug Vargatef

The European Medicines Agency last week approved Boehringer Ingelheim’s lung cancer drug Vargatef for treating non-small cell lung adenocarcinomas.

Vargatef (nintedanib), combined with docetaxel chemotherapy, treats a common but high-risk group of patients, the drugmaker said. Adults with this type of cancer tend to be diagnosed late in the disease and experience recurrence or metastasis after first-line chemotherapy. There are few second-line options, BI added.

Approval was based on global clinical trials that showed roughly 1,310 patients experienced more than a year of average overall survival compared with docetaxel alone, and a full quarter of those patients survived for at least two years.

Vargatef is BI’s second lung cancer drug to win approval since 2013, when European and U.S. regulators gave Giotrif (afatinib) the nod for patients whose lung tumors showed a specific mutation. Vargatef already is approved under the name Ofev in the U.S. to treat idiopathic pulmonary fibrosis, a little-understood disease that causes progressive loss of lung function.

BI said it is continuing to study the drug for NSCLC indications, as well as colorectal, liver, kidney and ovarian cancers and mesothelioma. — Lena Freund

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.