Genentech Seeks FDA Nod for T-DM1

Genentech, the South San Francisco-based unit of Roche, said it has turned in its application to the FDA to start selling a souped-up version of the hit breast cancer drug trastuzumab (Herceptin). The new antibody is attached to a toxin to give it more tumor-killing punch. The drug, known as T-DM1, was developed by Genentech with technology from Waltham, MA-based ImmunoGen (NASDAQ: [[ticker:IMGN]]). Last December, Genentech showed in a clinical trial it was able to completely or partially shrink tumors for about one-third of women who had received an average of seven prior rounds of treatment. I wrote an in-depth feature last month about the twists and turns of T-DM1’s development history.

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.