FDA Expansion Cohorts Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics

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Expansion Cohorts Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics[附网盘链接]是于过去发布的FDA标准，适用于US。

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Draft — Not for Implementation 1 Expansion Cohorts: Use in First-In-Human Clinical Trials to 2 Expedite Development of Oncology Drugs and Biologics 1

3 Guidance for Industry 4 5 6 7 8 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 9 Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 10 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 11 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 12 for this guidance as listed on the title page. 13 14 15 16 17 I. INTRODUCTION 18 19 The purpose of this guidance is to provide advice to sponsors regarding the design and conduct 20 of first-in-human (FIH) clinical trials intended to efficiently expedite the clinical development of 2

21 cancer drugs, including biological products, through multiple expansion cohort trial designs. 22 These are trial designs that employ multiple, concurrently accruing patient cohorts, where 23 individual cohorts assess different aspects of the safety, pharmacokinetics, and anti-tumor 24 activity of the drug. This guidance provides FDA’s current thinking regarding: (1) 25 characteristics of drug products best suited for consideration for development under a multiple 26 expansion cohort trial; (2) information to include in investigational new drug application (IND) 27 submissions to support the use of individual cohorts; (3) when to interact with FDA on planning 28 and conduct of multiple expansion cohort studies; and (4) safeguards to protect patients enrolled 29 in FIH expansion cohort studies. 30 31 This draft guidance is intended to serve as advice and as the starting point for discussions 3

32 between FDA, pharmaceutical sponsors, the academic community, and the public. This 33 guidance does not address all issues relating to clinical trial design, statistical analysis, or the 34 biomarker development process. Those topics are addressed in other guidances including the 35 International Conference on Harmonisation guidances for industry E9 Statistical Principles for 1

This guidance has been prepared by the Office of Hematology and Oncology Drug Products in the Center for Drug Evaluation and Research (CDER) in cooperation with the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration. 2

For the purposes of this guidance, all references to drugs or drug products include both human drugs and biological drug products regulated by CDER and CBER unless otherwise specified. 3

In addition to consulting guidances, sponsors are encouraged to contact the appropriate review division to discuss specific issues that arise during the development of cancer drugs. 1

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