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FDA News: Issue 23-1, December 2022

Author: [AUTHOR] Published on 12/23/2022 6:00:00 AM


FDA Announces Availability of a Final Guidance on Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of PD-1/PD-L1 Blocking Antibodies for Treatment of Patients with Cancer

On December 6, 2022, the US Food and Drug Administration (FDA) announced the availability of a final guidance for industry entitled  Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 (PD-1) or Programmed Cell Death-Ligand 1 (PD-L1) Blocking Antibodies for Treatment of Patients with Cancer. 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 for oncology products.

PD-1 and PD-L1 blocking antibody products have been developed for various cancer indications. These antibodies are usually administered intravenously. Sponsors may seek approval of alternative intravenous (IV) dosing regimens that are different from those tested in the original clinical efficacy and safety trials that served as the basis of approval of the current dosing regimen, or in the pre-approval setting, dosing regimens that differ from those tested in earlier PK and efficacy studies conducted during development. These alternative IV dosing regimens are typically designed to change doses and dosing intervals. Longer dosing intervals can minimize patient burden and reduce risks associated with more frequent administration (e.g., infusion reactions), as well as exposure to communicable diseases (e.g., SARS-CoV-2) associated with visits to hospitals or infusion centers. This guidance provides a PK-based approach to support approval of alternative dosing regimens for PD-1/PD-L1 blocking antibody products in both the pre- and post-approval setting. This paradigm may apply to PD-1/PD-L1 monotherapies, as well as combination regimens in which the dose and/or dose schedule of the PD-1/PD-L1 is the only proposed change.

The “Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 (PD-1) or Programmed Cell Death-Ligand 1 (PD-L1) Blocking Antibodies for Treatment of Patients with Cancer” guidance is available at: Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 (PD-1) or Programmed Cell Death-Ligand 1 (PD-L1) Blocking Antibodies for Treatment of Patients with Cancer | FDA. Please refer to the guidance for more details.


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This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.

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