Us2.ai receives FDA clearance for Us2.v2,transforming…

NEW YORK, August 10, 2011 – The genotyping era of melanoma management is poised to launch.

The era will start with genetic assessment of every patient with advanced-stage melanoma becoming the standard of care, as soon as the Food and Drug Administration approves marketing of vemurafenib, the small-molecule inhibitor of a mutated form of the BRAF gene. Reuters reports that approval is imminent, based on strikingly good results from a phase III study presented in June at the annual meeting of the American Society of Clinical Oncology, and published in the New England Journal of Medicine (2011;364:2507-16).

"If and when [vemurafenib] is approved by the FDA, we will need some sort of commercially available test to assess patients [with unresectable stage IIIC or stage IV melanoma] for BRAF [mutations]," Dr. Richard D. Carvajal said in an interview after speaking at the American Academy of Dermatology’s Summer Academy meeting. "In a large, phase III trial, vemurafenib impacted survival in patients with tumors with a BRAF mutation. You’ll need to know the BRAF status to use [vemurafenib]."