Home > Newsletters > FDAnews Drug Daily Bulletin > Panel Recommends Onyx Myeloma Drug, Votes Down Sanofi VTE Drug
FDAnews Drug Daily Bulletin
June 28, 2012 | Vol. 9 No. 127
Panel Recommends Onyx Myeloma Drug, Votes Down Sanofi VTE Drug
The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 11–0 with one abstention to recommend approval for Onyx Pharmaceuticals’ Kyprolis for patients with relapsed and refractory multiple myeloma who have received at least two prior lines of therapy. “This is an unmet need in a group that has really run out of options,” ODAC chair Wyndham Wilson said during the Wednesday meeting. Onyx seeks accelerated approval for Kyprolis (carfilzomib) based on the results of a Phase IIb trial, which found an overall response rate of 22 percent and median response duration of almost eight months.
Washington Drug Letter
ePublishing :: CMS, Hosting & Web Development | © Copyright by FDAnewsAll rights reserved. Do not duplicate or redistribute in any form.