Home » Posts tagged with » Melanoma

FDA Approves Vemurafenib for Advanced Melanoma

Clinical Context Melanoma is the leading cause of mortality from dermatologic conditions. In the United States in 2010, there were approximately 68,130 new diagnoses of melanoma and approximately 8700 melanoma-related deaths, according to estimates from the National Cancer Institute. On August 17, the US Food and Drug Administration (FDA) approved vemurafenib (Zelboraf, Plexxikon/Roche) for first-line treatment of metastatic and unresectable melanomas with V600E mutations in the BRAF gene. This type of BRAF mutation occurs in roughly half of melanomas. The mechanism of action of vemurafenib is to inhibit BRAF, thereby blocking the activity of the V600E-mutated BRAF protein. Vemurafenib is the second new drug approved this year for treatment of melanoma, the first being the immunotherapeutic agent ipilimumab (Yervoy, Bristol-Myers Squibb), which was approved in March. Along with vemurafenib, the FDA approved a companion diagnostic test, the cobas 4800 BRAF V600 Mutation Test, to detect the BRAF V600E mutation. Study Synopsis and Perspective The FDA approved the oral targeted therapy vemurafenib 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…