FDA’s NSCLC Guidance Stresses Overall Survival Endpoint, Sets PFS Standards
Executive SummaryFDA is using its new draft guidance on non-small cell lung cancer to once again stress the importance of using overall survival to prove efficacy and make clear that if progression-free survival measure is used, a “substantial and robust” effect should be shown.
You may also be interested in...
FDA’s final guidance on lung cancer trial endpoints says that overall survival is the optimal test of efficacy, but reaffirms that progression-free survival primary endpoint may support approval if the magnitude of effect is “substantial and statistically robust.”
Progression-free survival benefit fails to translate into overall survival in Phase III NSCLC study of c-Met inhibitor tivantinib, partnered with Daiichi Sankyo. ArQule shifts focus to an imminent, targeted second-line Phase III study of high-Met expressing hepatocellular cancer.
After a progression-free survival benefit failed to translate into overall survival in a Phase III NSCLC study of ArQule/Daiichi Sankyo’s c-Met inhibitor tivantinib, ArQule is shifting focus to an imminent, targeted second-line Phase III study in high-Met expressing hepatocellular cancer.