News
GSK's Votrient Clears ODAC Despite Outdated Trial, FDA Safety Concerns
GSK's RCC Agent Votrient Clears ODAC Despite Outdated Trial, FDA Safety Concerns
J Hammon
20090912
2009 Oct 12
The Pink Sheet Daily
GSK's Votrient Clears ODAC Despite Outdated Trial, FDA Safety Concerns
The Pink Sheet Daily. 2009 Oct 12, J Hammon
FDA might not always demand that a new oncologic be compared to the current standard of care if its trial was conducted before that standard was established, Office of Oncology Drug Products Director Richard Pazdur said at an Oct. 5 advisory committee meeting. The study under discussion was for GlaxoSmithKline's advanced renal cell carcinoma agent Votrient (pazopanib). The trial was positive, but was conducted against a placebo control outside the U.S., right about the time that five new kidney...
Meet Our Experts
Meet our Advisory and Editorial Boards comprised of physician editors and world-renowned experts.
Editors' Choice
Long-Term Posttransplant Bortezomib Boosts Outcome in Myeloma With del(17p13)
