The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced today its recommendation that Zelboraf (vemurafenib), an innovative protein-kinase inhibitor, used to treat metastatic or unresectable melanoma (where it cannot be surgically removed or has spread to other parts of the body) with BRAF V600 mutations, be granted marketing authorization.

Melanoma has a 90% survival rate when treated early, and is relatively easy to deal with, in part due to its location on the surface of the skin. However, its invasive nature means that if left too long, it becomes highly aggressive.

Of those with unresectable or metastatic melanoma, only a quarter of patients last more than a year with less than 15% left five years later. Thus, there is an urgent need for medicines to treat metastatic melanoma, which is the sixth most common malignancy in men and 7th most common in women, with around 60,000 new cases and more than 15,000 deaths a year attributed to this type of cancer.

In clinical trials Zelboraf was compared to the standard treatment of dacarbazine and was shown to improve progression free survival times by around four months, and overall survival times by about three months.

The CHMP looked at the risks of using the drug, which include the possibility of secondary neoplasms, including squamous cell carcinoma, but decided that the magnitude of risk is acceptably low. They also recommended that Roche had put in place the appropriate risk management so that the chances of secondary cancers can be managed by physicians, who can carry out routine monitoring of patients.

The committee concluded during its December 2011 meeting, that the benefits of making Zelboraf available to patients outweighed its risks. The CHMP’s recommendation is now being sent to the European Commission for the adoption of a binding decision.

The FDA approved Zelboraf back in August 2011.

Paul Brown, head of Roche Molecular Systems said :

“The cobas BRAF Mutation Test has improved sensitivity, accuracy and speed compared to other commonly used, unapproved detection methods … With a personalized medicine now available, all people diagnosed with inoperable or metastatic melanoma should be tested to help determine the best options for treatment.”

Written by Rupert Shepherd