Docket Number: FDA-2021-D-0691 Issued by:

Guidance Issuing Office

Oncology Center of Excellence

Center for Drug Evaluation and Research

This document provides recommendations for sponsors of investigational new drug applications (INDs) and biologics license applications (BLAs) under 42 U.S.C. § 262 and 21 CFR Parts 312 and 601 on the use of pharmacokinetic (PK)-based criteria to support the approval of alternative dosing regimens for programmed cell death receptor-1 (PD-1) or programmed cell death-ligand 1 (PD-L1) blocking antibodies. This guidance is based on accumulated scientific and regulatory experience for PD-1 and PD-L1 drugs, and as such, does not address development of alternative dosing regimens for other drugs or biologics, changes in route of administration, or novel formulations of previously-approved PD-1/PD-L1 products.

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All written comments should be identified with this document's docket number: FDA-2021-D-0691.