US FDA Dismisses Post-Progression Endpoint In Cyramza Lung Cancer Study
Lilly included progression-free survival 2 as an exploratory endpoint in RELAY on the advice of the European Medicines Agency and says study results show continuing benefit from first-line ramucirumab even after progression; FDA says endpoint is not valid for regulatory purposes and is subject to confounding.
You may also be interested in...
Oncologic Drugs Advisory Committee votes 6-5 that ramucirumab’s benefit/risk profile is favorable in first-line lung cancer, but 13-2 that pivotal trial data do not support approval of Steba’s vascular-targeted, photodynamic therapy for low-risk prostate cancer.
Oncologic Drugs Advisory Committee will consider whether a statistically significant benefit on progression-free survival, but no survival advantage, is enough to secure a first-line lung cancer indication for ramucirumab.
A protocol amendment is not needed to pause enrollment to decrease potential exposure to COVID-19, and virtual visits can be immediately implemented to ensure safety; experts say pandemic is forcing a rethinking in how companies carry out trials and in how regulators ensure patient safety and trial integrity.