Zelboraf (vemurafenib), For Deadly Skin Cancer, Approved In Europe

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Main Category: Melanoma / Skin Cancer
Also Included In: Regulatory Affairs / Drug Approvals;  Dermatology
Article Date: 21 Feb 2012 - 6:00 PST

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Zelboraf (vemurafenib), manufactured by Roche, has been approved by the European Commission, for treating patients with BRAF V600 mutation-positive metastatic melanoma, a deadly, and dangerous type of skin cancer. Zelboraf works by seeking out the mutated parts of the BRAF protein, found in about 50% of all melanoma cases, and blocking its action.

Hal Barron, M.D., head of Global Product Development and Chief Medical Officer at Roche said:

"Today's approval is important news for people with BRAF mutation-positive metastatic melanoma as Zelborad significantly improves patient survival and exemplifies the benefits that Roche's personalized approach to medicine can provide for patients, physicians, and society."

The Roche cobs 4800 BRAF V600 Mutation Test, a diagnostic test co-designed by Roche, to figure out which patients were eligible for treatment, showed that Zelboraf is the only known treatment which benefits the survival rates in some patients with accelerated melanoma who possess the BRAF V600 mutation, and who have been treated before or have not previously been treated.

Zelboraf tests showed many improvements, compared with chemotherapy. The risk of mortality was lowered by 63% in patients who received Zelboraf. It greatly improved life expectancy, compared to normal treatment by an overall survival rate of 13.2 months. Chemotherapy treatment usually gives patients a 9.6 month window of life expectancy after treatment.

Zelboraf became the only and the first FDA (Food and Drug Administration) approved medicine for improving survival rates among people with the BRAF V600 mutation in 2011. It was approved at the same time as the cobas 4800 BRAF V600 Mutation Test. Currently, they are both approved for use in the U.S., are CE-marked, and are commercially available in the EU.

Other countries which have recently approved the use of Zelboraf include: Israel, Brazil, Switzerland and New Zealand. Australia, India, and other countries around the world are reviewing the possibility of using Zelboraf. While other countries are reviewing Zelboraf and Roche awaits approval, a world-wide study for safety is giving Zelboraf to over 2000 people who have previously been treated, or not, for BRAF V600 mutation-positive metastatic melanoma.

All studies conducted regarding the safety of Zelboraf showed consistency.

Zelboraf, used for the monotherapy of adults with BRAF mutation positive unresectable or metastatic melanoma, is an oral-shaped, small molecule, kinase inhibitor. It is not recommended for melanoma patients who possess wild-type BRAF.

Melanoma, when it spreads to other parts of the body after the first diagnosis, is deadly. However, if found early, this type of cancer can be treated. A person with melanoma usually does not have a long life expectancy, sometimes only a few months. Normally, as little as 1 in 4 patients can be expected to live a year after being diagnosed.

About Mutation Testing Using BRAF V600

• It is a polymerase chain reaction-based diagnostic test
• It was developed by RocheM
• It is now FDA approved in certain countries, and has been confirmed in the BRIM2 and BRIM3 tests to find tumors which carry the BRAF 4600E mutation. (These mutations happen in eight percent of all tumors)
• It has been compared to Sanger sequencing, and has been proven recently to be better than this commonly used method. It is more sensitive and reliable than the Sanger sequencing in terms of finding mutations and gives quicker results.

BRIM2, a phase II study, enlisted 132 volunteers who had previously been treated for the V600E mutation-positive melanoma, and BRIM3, a phase III study, compared Zelboraf to dacarbazine chemotherapy in 675 patients who had previously not been treated for the V600E mutation-positive melanoma.

Zelboraf is being co-developed between Roche and Plexxikon(a Daiichi Sankyo Group member), with a 2006 license and collaboration contract.

Written By Christine Kearney

Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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