Vargatef (nintedanib), developed by Boehringer Ingelheim, is a cancer medicine used to treat adults with a subtype of non-small cell lung cancer (NSCLC) called adenocarcinoma.

The therapy has been approved in the European Union for adenocarcinoma patients whose cancer has returned or spread following a first-line chemotherapy, in combination with another cancer drug, Taxotere (docetaxel). Vargatef is not approved by the U.S. Food and Drug Administration (FDA).

How Vargatef works

It is an oral triple angiokinase inhibitor that works by blocking the activity of enzymes called tyrosine kinases. These can be found in some receptors found on the surface of cancer cells and surrounding tissue, namely blood vessels, where they activate processes that include those involving cell division and the growth of new blood vessels. By blockingtyrosine kinases, Vargatef helps to reduce the growth and spread of the cancer by cutting off the blood supply that keeps cancer cells growing.

Vargatef in clinical trials

A Phase 3 study (NCT00805194), called LUME-Lung 1, tested Vargatef in 1,314 people with locally advanced or metastatic NSCLC who had already been treated with a first-line chemotherapy. The study demonstrated that, when added to Taxotere, Vargatef was more effective than docetaxel alone at delaying cancer progression. Progression-free survival in these patients was better in those given the combination treatment, and — in patients with advanced adenocarcinoma,  specifically, overall survival was 12.6 months in those treated with Vargatef plus docetaxel, and 10.3 months in patients given docetaxel alone.

The combination also showed a manageable adverse event profile, without compromising the participants’ quality of life.

Based on these results, the use of Vargatef plus Taxotere was authorized by the European Medicines Agency (EMA) in November 2014, following a finding by its Committee for Medicinal Products for Human Use (CHMP) that its benefits were greater than its risks.

Other details

It is taken orally. The recommended dose is 200 mg taken twice a day.

Special attention must be taken not to take Vargatef on the same day as Taxotere. Usually, Taxotere is given on the first day of a 21-day treatment cycle, therefore, Vargatef should be started on the second day.

Common side effects include diarrhea, vomiting, and increased levels of some liver enzymes in the blood.

The drug is currently not approved in the U.S.

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