BURROUGHS WELLCOME NAVELBINE REQUIRES ADDITIONAL STUDY FOR BREAST CANCER INDICATION, FDA CMTE. FINDS; FDA's BURKE URGES MORE FIRST-LINE COMBO THERAPY
Executive Summary
Burroughs Wellcome will need an additional randomized trial to gain an approval recommendation for Navelbine in the treatment of breast cancer, FDA's Ontologic Drugs Advisory Committee indicated at its June 7 meeting.