Swiss group Roche Holding AG’s Zelboraf (vemurafenib), treatment for BRAF V600 mutation-positive unresectable or metastatic melanoma which works by protein-kinase inhibition, was recommended for approval by the European Union’s Committee for Medicinal Products for Human Use (CHMP).
Melanoma is one of the deadliest forms of skin cancer leading to one in four people expected to live for only 12 months after their diagnosis. It is the sixth most common malignancy and seventh most common malignancy in men and women respectively. In Europe, about 60,000 new cases of melanoma are diagnosed annually.
Zelboraf was approved by U.S. Food and Drug Administration (FDA) on August 17, 2011.
“The CHMP recommendation to approve Zelboraf represents an important milestone for people with metastatic melanoma who until recently had limited treatment options,” Hal Barron, M.D., chief medical officer and head, Global Product Development, said in a statement. “We are working closely with health authorities worldwide to bring Zelboraf to people with this deadly disease as soon as possible.”
Following review of all available data, the Committee concluded during its December 2011 meeting that the benefits of Zelboraf, particularly the improvements seen in terms of PFS and OS of patients, outweigh its risks, and recommended that a marketing authorisation should therefore be granted.