The drug, also known as vemurafenib, is targeted for the treatment of patients with melanoma whose tumors express the gene mutation BRAF V600E. Zelboraf was approved with a first-of-a-kind test called the cobas 4800 BRAF V600 Mutation Test, a companion diagnostic that will help determine if a patient's melanoma cells have the BRAF V600E mutation, FDA officials says.
Dr. Richard Pazdur, director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research, says the BRAF protein is normally involved in regulating cell growth, but is mutated in about half of the patients with late-stage melanomas.
Zelboraf is a BRAF inhibitor that is able to block the function of the V600E-mutated BRAF protein, Pazdur says.
"This has been an important year for patients with late-stage melanoma. Zelboraf is the second new cancer drug approved that demonstrates an improvement in overall survival," Pazdur says in a statement.
"In March, we approved Yervoy (ipilimumab), another new treatment for late-stage melanoma that also showed patients live longer after receiving the drug."
Zelboraf was reviewed under the FDA's priority review program that provides for an expedited six-month review of drugs that may offer major advances in treatment or that provide a treatment when no adequate therapy exists.