What is Vargatef - nintedanib and what is it used for?
Vargatef is a cancer medicine used in the treatment of adult patients with a type of lung cancer known as non-small cell lung cancer. Vargatef is used in the treatment of a type of non-small cell lung cancer called "adenocarcinoma", when the tumor is locally advanced, metastatic (ie when cancer cells have spread from the original site to other parts of the body) or locally recurrent (ie when the tumor reappeared in the same area). The medicine is used in combination with a chemotherapy drug called docetaxel in patients who have already undergone previous chemotherapy therapy. Vargatef contains the active ingredient nintedanib .
How is Vargatef - nintedanib used?
Vargatef can only be obtained with a prescription and treatment should be started and followed by a doctor experienced in the use of anticancer medicines. Vargatef is available as capsules (100 and 150 mg) to be taken by mouth, preferably with food. The recommended dose is 200 mg taken twice a day (approximately 12 hours apart). Since Vargatef should not be taken the same day as docetaxel and since docetaxel is given on day 1 of a 21-day course of treatment, Vargatef should be taken from day 2 to day 21, while docetaxel is given on day 1. Treatment with Vargatef may continue after discontinuation of docetaxel until the patient's condition improves or stabilizes and the side effects are tolerable. In the event of serious side effects, your doctor may decide to stop treatment with Vargatef and resume it at a reduced dose. In case of persistence of serious side effects, the treatment must be permanently interrupted. For more information, see the package leaflet.
How does Vargatef - nintedanib work?
The active substance in Vargatef, nintedanib, blocks the activity of some enzymes known as tyrosine kinases. These enzymes can be present inside some receptors (such as VEGF, FGF and PDGF receptors) on the surface of tumor cells and on cells of the surrounding tissue (for example, blood vessels), where they activate different processes including cell division and the growth of new blood vessels. By blocking these enzymes, nintedanib helps reduce the growth and spread of the tumor and interrupt the blood supply that allows cells to grow.
What benefit has Vargatef - nintedanib shown during the studies?
In one main study involving 1 314 patients with advanced or recurrent small cell lung cancer who did not respond to previous treatment, Vargatef taken in combination with docetaxel was shown to be more effective than docetaxel taken on its own in delay tumor progression. Progression-free survival (the period of time elapsed without worsening the disease) was 3.5 months in patients treated with Vargatef and docetaxel compared to 2.7 months in patients treated with docetaxel alone. Furthermore, Vargatef led to an improvement in overall survival (the patient's lifespan) in the subgroup of patients with non-small cell adenocarcinoma-type lung cancer: overall survival was 12.6 months in patients treated with Vargatef and docetaxel compared to 10.3 months in patients treated only with docetaxel.
What is the risk associated with Vargatef - nintedanib?
The most common side effects with Vargatef (which may affect more than 1 in 10 people) are diarrhea, vomiting and increased blood levels of certain liver enzymes (a sign of possible liver problems). Vargatef should not be used in people who are hypersensitive (allergic) to nintedanib, peanuts or soy or any of the other ingredients. For the full list of all side effects and restrictions with Vargatef, see the package leaflet.
Why has Vargatef - nintedanib been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Vargatef's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP noted that Vargatef is effective in slowing the progression of the disease and prolonging life in the subgroup of patients with non-small cell adenocarcinoma lung cancer. As for safety, although a greater number of undesirable effects have been reported in patients treated with Vargatef and docetaxel compared to subjects treated with docetaxel as monotherapy, the undesirable effects were considered manageable by dose reductions, supportive treatments and interruptions of therapy.
What measures are being taken to ensure the safe and effective use of Vargatef - nintedanib?
A risk management plan has been developed to ensure that Vargatef is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vargatef, including the appropriate precautions to be followed by healthcare professionals and patients. In addition, the company that markets Vargatef will conduct studies to develop ways of identifying patients who are more likely to benefit from treatment with the medicine. Further information is available in the summary of the risk management plan.
More information on Vargatef - nintedanib
On 21 November 2014, the European Commission issued a marketing authorization for Vargatef, valid throughout the European Union. For more information on Vargatef therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 11-2014.
