Ventana Medical Systems
This article was originally published in The Gray Sheet
Executive Summary
Premarket approval application is submitted for the CB11 antibody for use by physicians in deciding whether metastatic breast cancer patients should receive Genentech's Herceptin drug. While Herceptin is intended to treat metastatic breast cancer patients that test positive for Her-2/neu receptor overexpression, the firm believes CB11 is better at predicting response to the therapy than polyclonal antibodies to Her-2/neu