Abbott Xinlay Lack Of Efficacy, CV Safety Will Be Likely Focus Of Advisory Cmte. Review
This article was originally published in The Pink Sheet Daily
Executive Summary
Meta-analysis of two failed studies of atrasentan in hormone refractory prostate cancer requires confirmation in independent studies, FDA says.
You may also be interested in...
Abbott Xinlay Not Ready For Approval Or Abandonment, Committee Says
FDA's Oncologic Drugs Advisory Committee unanimously recommends against approval of Abbott's prostate cancer therapy atrasentan.
Abbott Xinlay Not Ready For Approval Or Abandonment, Committee Says
FDA's Oncologic Drugs Advisory Committee unanimously recommends against approval of Abbott's prostate cancer therapy atrasentan.
Ongoing Phase III Study Could Provide Xinlay Back-Up Option, Abbott Says
Abbott is counting on its back-up Phase III study to support Xinlay approval should FDA reject the current application, which uses a meta-analysis of subgroups from two failed trials