Vargatef - nintedanib

What is Vargatef - nintedanib and what is it used for?

Vargatef is an anticancer medicine used to treat adult patients with a type of lung cancer known as non-small cell lung cancer.Vargatef is used to treat a type of non-small cell lung cancer called 'adenocarcinoma', when the cancer 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 has come back in the same area.) The medicine is used in combination with a chemotherapy medicine called docetaxel in patients who have already received previous chemotherapy. Vargatef contains the active substance nintedanib.

How is Vargatef used - nintedanib?

Vargatef can only be obtained with a prescription and treatment should be started and supervised 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 to be taken twice a day (approximately 12 hours apart). Since Vargatef should not be taken on the same day as docetaxel and because docetaxel is administered on day 1 of a 21-day treatment cycle, Vargatef is taken on days 2 to 21, while docetaxel is given on day 1. Treatment with Vargatef can continue after stopping docetaxel until the patient's condition improves or stabilizes and the side effects are tolerable. If serious side effects occur, your doctor may decide to stop treatment with Vargatef and restart it at a reduced dose. If serious side effects persist, treatment should be permanently discontinued. For more information, see the package leaflet.

How does Vargatef - nintedanib work?

The active substance in Vargatef, nintedanib, blocks the activity of certain enzymes known as tyrosine kinases. These enzymes may be present within some receptors (such as VEGF, FGF and PDGF receptors) on the surface of cancer cells and on cells. surrounding tissue (for example, blood vessels), where they activate various processes including cell division and the growth of new blood vessels. By blocking these enzymes, nintedanib helps to reduce the growth and spread of the tumor and to cut off the blood supply that allows cells to grow.

What benefit has Vargatef - nintedanib shown during the studies?

In a main study involving 1 314 patients with advanced or recurrent small cell lung cancer that did not respond to previous treatment, Vargatef taken in combination with docetaxel was shown to be more effective than docetaxel taken alone in delay tumor progression. Progression-free survival (the time that the disease did not get worse) was 3.5 months in patients treated with Vargatef and docetaxel compared to 2.7 months in patients treated with docetaxel alone. In addition, Vargatef led to improved overall survival (patient life span) in the subgroup of patients with "adenocarcinoma" type non-small cell lung cancer: overall survival was 12.6 months in patients treated with Vargatef and docetaxel compared to 10.3 months in patients treated with docetaxel alone.

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 some liver enzymes (a sign of possible liver problems). Vargatef must not be used in people who are hypersensitive (allergic) to nintedanib, peanut or soy or any of the other ingredients. For the full list of side effects reported with Vargatef and their limitations, 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 disease progression and prolonging life in the subgroup of patients with non-small cell lung cancer of the "adenocarcinoma" type. Regarding safety, although more undesirable effects have been reported in patients treated with Vargatef and docetaxel than in patients treated with docetaxel alone, undesirable effects were considered manageable through dose reductions, supportive treatments and discontinuation 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 added to the summary of product characteristics and package leaflet for Vargatef, including the appropriate precautions to be followed by healthcare professionals and patients. In addition, the company that markets Vargatef will carry out studies to find ways to identify patients who are more likely to benefit from treatment with the medicine. Further information can be found in the summary of the risk management plan.

Other information about Vargatef - nintedanib

On 21 November 2014, the European Commission granted a "Marketing Authorization" for Vargatef, valid throughout the European Union. For more information on Vargatef therapy, read the package leaflet (included with the EPAR) or consult your doctor. or the pharmacist. Last update of this summary: 11-2014.


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