Aveo’s Tivozanib Troubles Reflect Perils Of Ex-U.S. Studies
Executive Summary
Pivotal study for the renal cell carcinoma drug was conducted largely in Central and Eastern Europe, where limited access to second-line targeted therapies does not reflect the U.S. practice. In recommending against approval, FDA’s Oncologic Drugs Advisory Committee questioned the study results’ applicability to the U.S.
You may also be interested in...
Aveo Eyes Role For Tivozanib In US Kidney Cancer Market, Against The Odds
In the Phase III TIVO-3 study, tivozanib is associated with a trend toward adverse survival and trial has missing data issues.
Keep Makena Under Accelerated Approval Pending More Studies, AMAG Tells US FDA
AMAG outlines plans for retrospective real-world evidence studies, and possibly a new placebo-controlled trial with a primary endpoint of preterm birth <32 weeks, in a filing opposing the Center for Drug Evaluation and Research’s proposal to withdraw the drug.
2020 In Review: US FDA New Drug Office’s COVID-19 Response Aided By Reorganization
Office of New Drugs Director Peter Stein tells the Pink Sheet that last phase of massive reorg was complicated by pandemic restrictions that forced review staff to work remotely, but the structural overhaul resulted in smaller, more nimble review groups and the breaking down of silos that ultimately helped the agency’s response to the public health crisis.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: