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FDA Approves Roche's Companion Dx and Drug for Melanoma

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has approved Roche's drug and companion diagnostic test for late-stage unresectable melanoma.

The agency today approved Zelboraf (vemurafenib), co-developed with Daiichi Sankyo, for the treatment of patients with melanoma whose tumors express a gene mutation known as BRAF V600E. At the same time it approved the cobas 4800 BRAF V600 Mutation Test for determining whether a patient's melanoma cells have the mutation.

FDA reviewed Zelboraf under its 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," it said in a statement. Zelboraf was approved ahead of its Oct. 28 goal date, while the cobas 4800 BRAF V600 test was approved ahead of its Nov.12 goal date.

"Today's approval of 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, director the Office of In Vitro Diagnostic Device Evaluation and Safety in the FDA's Center for Devices and Radiological Health.

In a statement, Roche said that the cobas test, which is PCR-based, was clinically validated in two studies to identify tumors carrying the BRAF V600E mutation.

"The test has several advantages compared to Sanger sequencing, a commonly used method, including greater sensitivity and reliability for detecting mutations and quicker results, allowing doctors to know whether a person with inoperable or metastatic melanoma is eligible for treatment with Zelboraf," Roche said.

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