SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug and companion diagnostic test for the most dangerous type of skin cancer, the agency said Wednesday.
The FDA announced the approval of Genentech's and Daiichi Sankyo's Zelboraf (vemurafenib), for patients with late-stage melanoma that can't be removed by surgery. Genentech is the U.S. division of Swiss drug maker Roche.
The drug is approved for patients whose melanoma includes a gene mutation called BRAF V600E, and the drug has not been tested in patients whose tumors don't express the gene. As such, the drug is being approved alongside a test called the cobas 4800 BRAF V600 mutation test, a diagnostic test designed to determine whether a patient's melanoma cells have the mutation.
"This has been an important year for patients with late-stage melanoma," FDA Office of Oncology Drug Products director Richard Pazdur said. "Zelboraf is the second new cancer drug approved that demonstrates an improvement in overall survival."