By John Carroll
In a rare move, the FDA has stamped an early approval on Roche’s remarkable new melanoma drug, vemurafenib, giving it a green light on a potential new blockbuster two months ahead of its PDUFA (Prescription Drug User Fee Act) date. For Roche and Daiichi Sankyo, which will market the drug as Zelboraf, the approval marks another key milestone in the advancement of new cancer drugs specifically targeted to the molecular triggers of the disease.
"The FDA approval of Zelboraf marks a major step forward in personalizing the treatment of metastatic melanoma, a devastating disease that until this year had limited approved treatment options," says Hal Barron, MD, chief medical officer at Roche. Roche plans to sell a 6-month course of treatment, which targets the mutated BRAF gene, for $56,400.