Genentech, the South San Francisco-based unit of Roche, and its Berkeley, CA-based Plexxikon, a unit of Daiichi Sankyo, said today that the FDA has approved their new drug for certain patients with melanoma that has spread through the body. The FDA said the companies can now start selling vemurafenib (Zelboraf) for patients who have mutations of a protein called BRAF that is implicated in their melanoma. The drug, which showed startlingly positive results in clinical trials, was approved ahead of the FDA’s legal deadline of Oct. 28, an action the agency rarely takes.
Author: Luke Timmerman
Luke is an award-winning journalist specializing in life sciences. He has served as national biotechnology editor for Xconomy and national biotechnology reporter for Bloomberg News. Luke got started covering life sciences at The Seattle Times, where he was the lead reporter on an investigation of doctors who leaked confidential information about clinical trials to investors. The story won the Scripps Howard National Journalism Award and several other national prizes. Luke holds a bachelor’s degree in journalism from the University of Wisconsin-Madison, and during the 2005-2006 academic year, he was a Knight Science Journalism Fellow at MIT.
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