ODAC To Review Pfizer’s Fragmin, Genta’s Genasense, Abraxis Bioscience’s Abraxane
This article was originally published in The Pink Sheet Daily
Executive Summary
The three products will be reviewed by the FDA advisory committee Sept. 6-7.
You may also be interested in...
Abraxane Randomized Trial Needed For Adjuvant Breast Cancer, Panel Says
ODAC votes in favor of Abraxis conducting an additional clinical trial to extend Abraxane’s indication from metastatic breast cancer into the adjuvant setting during a Sept. 7 meeting.
Abraxane Randomized Trial Needed For Adjuvant Breast Cancer, Panel Says
ODAC votes in favor of Abraxis conducting an additional clinical trial to extend Abraxane’s indication from metastatic breast cancer into the adjuvant setting during a Sept. 7 meeting.
Oncology Panel To Determine Whether Abraxane Needs Randomized Trial In Adjuvant Breast Cancer
The committee will consider if previous studies of Bristol’s Taxol, which has the same active ingredient as Abraxane, are sufficient to support approval via the 505(b)(2) pathway.