US panel rejects breast cancer indication for J&J's Doxil
This article was originally published in Scrip
Executive Summary
The US FDA's oncologic drugs advisory committee has unanimously recommended against adding a breast cancer indication to Centocor Ortho Biotech's (Johnson & Johnson) anthracycline chemotherapeutic Doxil (pegylated liposomal doxorubicin). The committee said that the addition of Doxil to Sanofi-Aventis's Taxotere (docetaxel) in first-line metastatic patients did not represent a favourable risk/benefit analysis.