Plexxikon Inc.: New Drug Applications Submitted for Vemurafenib Market Approval in Melanoma
5/11/2011 10:20:00 AM
Plexxikon Inc., a member of the Daiichi Sankyo Group, today announced that applications for market approval for vemurafenib (PLX4032/RG7204) for the treatment of metastatic melanoma have been submitted to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Additionally, a pre-marketing application for approval for a companion diagnostic test has been submitted in the U.S.; the test also will be registered in Europe. Vemurafenib is an oral drug that selectively targets the BRAF V600 mutation, which occurs in about half of all cases of melanoma and eight percent of all solid tumors. The companion diagnostic determines whether a patient’s tumor tests positive for the BRAF mutation and is eligible to receive vemurafenib treatment.