| FDA Announces Availability of a Draft Guidance on PK-Based Criteria for Supporting Alternative Dosing Regimens of PD-1 or PD-L1 Blocking Antibodies for the Treatment of Patients with Cancer | | | On August 26, 2021, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance for industry titled "Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 (PD-1) or Programmed Cell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 This draft guidance describes the FDA's recommendations for sponsors of investigational new drug applications (INDs) and biologics license applications (BLAs) on the use of pharmacokinetic (PK)-based criteria to support the approval of alternative dosing regimens for PD-1 or PD-L1 blocking antibodies. 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 clinical efficacy and safety trials. These alternative IV dosing regimens are typically designed to change doses (e.g., body weight adjusted doses to flat doses) and/or dosing intervals (e.g., once every 3 weeks to once every 6 weeks). Longer dosing interval periods 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). This guidance describes how a PK-based approach relying on population-PK (Pop-PK) modeling and simulation can be applied to support the approval of alternative dosing regimens for a PD-1 or PD-L1 blocking antibody that is already approved based on clinical efficacy and safety trials. 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Receptor-1 (PD-1) or Programmed Cell Death-Ligand 1 (PD-L1) Blocking Antibodies for Treatment of Patients with Cancer" draft guidance is available at https://go.usa.gov/xFe9m. Please refer to the draft guidance for more details. FDA is publishing this draft guidance to collect additional public comments. You may submit your comments regarding the draft guidance to the docket (Docket No. FDA-FDA-2021-D-0691) available at https://www.regulations.gov up to 60 days following publication in the FEDERAL REGISTER. This draft guidance, when finalized, will represent the current thinking of the FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. Your comments can impact the outcomes of FDA regulatory policy, so share your knowledge and experience. | | | The Office of Clinical Pharmacology (OCP) is pleased to offer the e-mail subscription service Clinical Pharmacology Corner. This is a free service from FDA to provide occasional updates from OCP regarding newly approved therapies, new regulatory and scholarly publications, upcoming events and other items of interest. Subscribe today at https://public.govdelivery.com/accounts/USFDA/subscriber/topics and select Clinical Pharmacology Corner under Drugs. We always welcome your thoughts regarding the format, content, and utility of this communication. Comments may be sent via email to ocp@fda.hhs.gov. This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA. | | | |
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