US FDA reviewers question benefits of Merck/Ariad, GSK sarcoma drugs
This article was originally published in Scrip
Executive Summary
With only small differences in median progression-free-survival (PFS) and overall survival between ridaforolimus, an experimental mTOR inhibitor under development by Merck and Ariad, and placebo, but particularly concerning adverse events of pneumonitis, infection and renal failure and impairment in study participants receiving the investigational drug, the US FDA wants its panel of outside advisers to weigh in on whether the product’s risk-benefit is favorable enough to approve the medicine as a maintenance therapy in patients with soft tissue and bone sarcomas.