FDA’s NSCLC Guidance Stresses Overall Survival Endpoint, Sets PFS Standards
FDA is using its new draft guidance on non-small cell lung cancer to once again stress the importance of using overall survival to prove efficacy and make clear that if progression-free survival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.
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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.