FDA Seeks Input On Acceptable Trial Design For Assessing Predictive Biomarkers
This article was originally published in The Pink Sheet Daily
Executive Summary
The Oncologic Drugs Advisory Committee will determine the legitimacy of retrospective trials used to determine predictive biomarkers during review of K-ras data for Erbitux and Vectibix.
You may also be interested in...
Amgen/Takeda To Re-start Motesanib Lung Cancer Trial
Amgen and partner Takeda are getting set to re-start a Phase III trial of the vascular endothelial growth factor inhibitor motesanib in non-small cell lung cancer, after a conditional go-ahead from an independent data monitoring committee
Amgen/Takeda To Re-start Motesanib Lung Cancer Trial
Amgen and partner Takeda are getting set to re-start a Phase III trial of the vascular endothelial growth factor inhibitor motesanib in non-small cell lung cancer, after a conditional go-ahead from an independent data monitoring committee
Motesanib Gets Green Light In Lung Cancer Trial
Amgen/Takeda now altering Phase III design for a smaller patient pool.