Burroughs Wellcome's Navelbine

Executive Summary

Vinorelbine NDA (20-388) will be reviewed by FDA's Oncologic Drugs Advisory Committee June 7 for the treatment of patients with metastatic breast cancer who have failed standard chemotherapy or who have relapsed within six months of anthracycline-based adjuvant therapy. The NDA was submitted March 31. The committee will also discuss the National Cancer Institute's Tamoxifen Breast Cancer Prevention Trial. The committee meeting will begin at 8:00 a.m., in conference rooms D&E of FDA's Parklawn Building