FDA Oncologic Drugs Advisory Committee

Executive Summary

Topics on the first day at the Dec. 19-20 meeting include Bristol-Myers Paraplatin (carboplatin), for treatment of stages III and IV ovarian cancer, and approval guidelines for drugs in treating bladder cancer. Second-day discussions will focus on Asta Pharma's Uromitexan (mesna), for use with ifosfamide as a uroprotective agent, and Stuart's Nolvadex (tamoxifen) supplemental NDA for treatment of premenopausal advanced breast cancer. Meeting begins at 9:00 a.m. both days in Conference Rooms D and E at FDA's Parklawn Building....