Daiichi Sankyo reported that applications for market approval for vemurafenib for the treatment of metastatic melanoma to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Vemurafenib is an oral, novel drug that targets the oncogenic BRAF mutation present in about half of melanoma cancers and about eight percent of all solid tumors.
Genentech, a member of the Roche Group submitted a New Drug Application for vemurafenib (RG7204, PLX4032) to the U.S. Food and Drug Administration (FDA). Roche submitted a Marketing Authorization Application to the European Medicines Agency (EMA) .
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. In April 2011, Daiichi Sankyo acquired Plexxikon, which discovered and is co-developing vemurafenib with Roche. Daiichi Sankyo will co-promote vemurafenib in the United States with Genentech under Plexxikon’s co-promotion agreement with them.
“The NDA submission to FDA for vemurafenib only six years after its discovery reflects Plexxikon’s highly efficient research platform to identify unique molecules as well as the team’s strategic approach to early development,” said Glenn Gormley, MD, PhD, chief science officer, and president, Daiichi Sankyo Pharma Development.
Release Date: May 11, 2011
Source: Daiichi Sankyo
Filed Under: Drug Discovery
