FDA Evaluating Cancer Drugs in Patients with Central Nervous System Metastases Guidance for Industry

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Evaluating Cancer Drugs in Patients with Central Nervous System Metastases Guidance for Industry[附网盘链接]是于不久前发布的FDA标准，适用于US。

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Evaluating Cancer Drugs in Patients with Central Nervous System Metastases 1

Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page. I. INTRODUCTION The purpose of this guidance is to describe FDA’s recommendations for clinical trial designs of 2

cancer drugs or biological products regulated by CDER and CBER that are intended to support product labeling describing the antitumor activity in patients with central nervous system (CNS) metastases from solid tumors originating outside the CNS. FDA’s current thinking regarding inclusion of patients with brain metastases in clinical trials is addressed in the guidance for industry Cancer Clinical Trial Eligibility Criteria: Brain 3

Metastases (July 2020). The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidance means that something is suggested or recommended, but not required.. II. BACKGROUND The solid tumors that most often metastasize to the CNS are small cell and non-small cell lung 4

cancers, breast cancer, melanoma, and renal cancers. CNS metastatic disease includes parenchymal metastases to the brain or spinal cord, as well as leptomeningeal disease (LMD) involving the pia, subarachnoid leptomeninges, and cerebrospinal fluid (CSF). LMD may present 1

This guidance has been prepared by the Oncology Center of Excellence (OCE), the Center for Drug Evaluation and Research (CDER), and the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration. 2

For purposes of this guidance, references to drugs include drugs approved under section 505 of the FD&C Act (21 U.S.C. 355) and biological products licensed under section 351 of the Public Health Service Act (42 U.S.C. 262). 3

We update guidances periodically. For the most recent version of a guidance, check the FDA guidance web page at https://www.fda.gov/RegulatoryInformation/Guidances/default.htm. 4

Nayak L, Lee EQ, Wen PY, 2012, Epidemiology of Brain Metastases, Curr Oncol Rep, 14(1): 48-54.

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