FDA’s NSCLC Guidance Stresses Overall Survival Endpoint, Sets PFS Standards
By
Emily Hayes / Email the Author / “The Pink Sheet” Jul. 4, 2011, Vol. 73, No. 27
Regulatory Update / Word Count: 760 / Article # 00110627009
Executive Summary
FDA is using its new draft guidance on non-small cell lung cancer to once again stress the importance of using overall survival to prove efficacy and make clear that if progression-free survival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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