Jefferson University Hospitals

Thomas Jefferson University Hospital First Academic Medical Center to Offer FDA-Approved BRAF Mutation Test for Melanoma Patients

11/08/11

Thomas Jefferson University Hospital is the first academic medical center in the United States to offer the recently-approved U.S. Food and Drug Administration (FDA) diagnostic tool that tests melanoma patients for the BRAF mutation (which occurs in about half of all cases) and ultimately determines if they’ll benefit from a new, potentially life-saving drug.

In August, the FDA approved the oral drug vemurafenib to treat patients whose melanoma cells have the BRAF V600E mutation, as determined by the companion diagnostic test, after clinical trials showed that the drug significantly extended survival in metastatic melanoma patients with the mutation.

Jefferson’s clinical laboratories have officially begun utilizing the FDA-approved test to help determine melanoma patients’ status and a subsequent and immediate treatment plan. According to Roche Diagnostics, its tool has improved sensitivity, accuracy and speed compared to other commonly used detection methods.

“It is very important to us at Jefferson to offer patients a personalized approach, starting with the pathology of their diseases all the way through their treatment,” says Stephen C. Peiper, M.D., Peter A. Herbut Professor and Chair of the Department of Pathology, Anatomy and Cell Biology at Thomas Jefferson University.

“Melanoma is a deadly skin cancer, and this FDA-approved diagnostic tool plays a pivotal role in our approach to it. The BRAF mutation test will allow us to quickly and accurately identify patients here at the hospital who will respond positively to this new treatment,” he adds.

An estimated 50 percent of patients with melanoma have this type of mutation.

The FDA approval of vemurafenib is based on results from two clinical studies in people with BRAF V600E mutation-positive, inoperable or metastatic melanoma as determined by the mutation test.

The risk of death was reduced by 56 percent for people who received vemurafenib compared to those who received chemotherapy. People who received vemurafenib also had a 74 percent reduced risk of the disease getting worse or dying compared to those who received chemotherapy. The confirmed investigator-assessed response rate (those who experienced tumor shrinkage) in people who received vemurafenib was 48.4 percent compared to 5.5 percent for those who received chemotherapy.

Vemurafenib is a BRAF inhibitor that blocks the function of the V600E-mutated BRAF protein and should be used only in people whose inoperable or metastatic melanoma carries a mutation.

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