Vemurafenib [Zelboraf] Approved Together with a Companion Diagnostic Test by FDA for Advanced Melanoma in BRAF V600E Positive Patients

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August 17, 2011 — The US Food and Drug Administration (FDA) has just approved the oral targeted therapy Vemurafenib [Zelboraf] for the first-line treatment of both metastatic and unresectable melanomas. The drug is specifically indicated for patients with melanoma whose tumors have V600E mutations in the BRAF gene. An estimated 50% of patients with melanoma have this type of BRAF mutation, which does not occur in normal cells. The drug is not indicated for use in melanoma patients negative for the BRAF V600E mutation. Vemurafenib [Zelboraf] is a BRAF inhibitor that blocks the function of the V600E-mutated BRAF protein.

Vemurafenib [Zelboraf] has been approved with a companion diagnostic test that will help determine whether a patient’s melanoma cells have the BRAF V600E mutation. The first-of-a-kind test is known as the cobas 4800 BRAF V600 Mutation Test (by Roche Molecular Systems).

The approval of Vemurafenib [Zelboraf] and the cobas test is a great example of how companion diagnostics can be developed and used to ensure patients are exposed to highly effective, more personalized therapies in a safe manner,” said Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostic Device Evaluation and Safety in the FDA’s Center for Devices and Radiological Health. The FDA’s approval of the cobas 4800 BRAF V600 Mutation Test was based on data from the same study that evaluated the safety and effectiveness of Vemurafenib [Zelboraf].

Vemurafenib [Zelboraf] was reviewed under the FDA’s priority review program that provides for an expedited 6-month review of drugs that may offer major advances in treatment or that provide a treatment when no adequate therapy exists, says the agency.

“This has been an important year for patients with late-stage melanoma. Vemurafenib [Zelboraf] is the second new cancer drug approved that demonstrates an improvement in overall survival,” said Richard Pazdur, MD, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research, in a press statement. “In March, we approved Ipilimumab [Yervoy], another new treatment for late-stage melanoma that also showed patients live longer after receiving the drug.”

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Joseph Gut - thasso Ph.D.; Professor in Pharmacology and Toxicology. Senior expert in theragenomic and personalized medicine and individualized drug safety. Senior expert in pharmaco- and toxicogenetics. Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.
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