News of World Medicine

The second preparation for treatment of melanoma has been approved in the USA

Food and Drug Administration (FDA) has approved a new preparation for treatment of virulent type of skin cancer.

Zelboraf, produced by the company Genentech (American subdivision of Swiss pharmaceutical giant Roche), has become the second preparation for melanoma, suggested for recent thirteen years and approved this year (in March FDA approved the use of Yervoy (ipilimumab).

Clinical studies of the preparation on 675 patients have shown that it works better than traditional chemotherapy, as it is aimed at genetic mutation, which is present in half of cancer patients. And in spite of the fact that the medication is not yet able to treat patients with metastatic melanoma, specialists call FDA’s decision "a really important event".

Zelboraf (which second name is vemurafenib) is effective only in patient with melanoma in progressive stage, when the tumor expresses genetic mutation BRAF V600E. There are about 10 thousand such patients only in the USA. The preparation blocks the protein that takes part in the process of cell growth. In order to decide if it is possible to treat the patient with vemurafenib, doctors will distinguish the type of cancer with the help of diagnostic analysis, which is called cobas 4800 BRAF V600 mutation test.

Preparations for melanoma, which exist today, practically are not able to prolong patient’s life. The majority of people with neglected melanoma die within 11 months. Last year there were registered 68,130 new cases in the USA; more than a half of the patients are under 59 years old; in 2010 this type of cancer took lives of about 8,700 Americans. According to the World Health Organization, annually skin cancer leads to 66,000 deaths all over the world, 80% of which are due to melanoma.

In the United States Zelboraf will become available at the market within two weeks. It is also known, that Roche has applied for registration of this new preparation in EU countries, as well as in Australia, New Zealand, Brazil, India, Mexico and Canada.


Adopted from: Eurolab.