Federal Register Notice: FDA will hold a meeting of the Oncologic Drugs Advisory Committee 3/3, from 8 a.m. to 5 p.m. and 3/4, from 8 a.m. to 1 p.m. at the Hilton, The Ballrooms, 620 Perry Pkwy., Gaithersburg, MD. The committee will (1) discuss an Advanced Magnetics NDA for Combidex (ferumoxtran-10), for intravenous administration as a magnetic resonance imaging contrast agent to assist in the differentiation of metastatic and nonmetastatic lymph nodes in patients with confirmed primary cancer who are at risk for lymph node metastases, and (2) discuss prostate cancer endpoints as a followup to the 6/04 FDA workshop. On 3/4, the committee will (1) discuss the results of a confirmatory trial for AstraZeneca Pharmaceuticals; NDA for Iressa for treating patients with locally advanced or metastatic nonsmall cell lung cancer after failure of both platinum-based and docetaxel chemotherapies, and (2) discuss safety concerns, specifically osteonecrosis of the jaw, associated with two bisphosphonates, Novartis Pharmaceuticals’ Zometa (zoledronic acid) injection and Aredia (pamidronate disodium for injection. Contact Johanna M. Clifford, (301) 827-7001. To view this notice, click here.
