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 for industry
- Collection:
- Health Policy and Services Research
- Contributor(s):
- United States. Food and Drug Administration. Office of Medical Products and Tobacco. Oncology Center of Excellence, issuing body. Center for Drug Evaluation and Research (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, December 2022
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Government Regulation Immune Checkpoint Inhibitors -- administration & dosage Immune Checkpoint Inhibitors -- pharmacokinetics Programmed Cell Death 1 Receptor -- administration & dosage United States United States. Food and Drug Administration
- Genre(s):
- Guideline Technical Report
- Abstract:
- This document provides recommendations for sponsors of investigational new drug applications (INDs) and biologics license applications (BLAs) under 42 U.S.C. ยง 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 PD1 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 PD1/PD-L1 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.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (4 pages))
- NLM Unique ID:
- 9918590085606676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918590085606676