New Drug Application Submitted for Vemurafenib in Melanoma


Get Permission

fdalogoDaiichi Sankyo announced that applications have been submitted for market approval for vemurafenib (PLX4032/RG7204) for the treatment of metastatic melanoma to the FDA and the European Medicines Agency (EMA). Additionally, a premarketing application for approval for a companion diagnostic test has been submitted in the United States. Vemurafenib is an oral, novel drug that targets the oncogenic BRAF mutation present in about half of melanoma cancers and about 8% of all solid tumors.

In April 2011, Daiichi Sankyo, Co, Ltd, acquired Plexxikon, which discovered and is co-developing vemurafenib with Roche. Daiichi Sankyo, Inc, will copromote vemurafenib in the United States with Genentech under Plexxikon’s copromotion agreement with Genentech, a member of the Roche Group. ■



Advertisement

Advertisement



Advertisement