FDA releases draft guidelines for alternative dosing regimens for PD-1 and PD-L1 cancer immunotherapy

The U.

Programmed cell death receptor-1 (PD-1) and programmed cell death ligand 1 (PD-L1) blocking antibodies have become the mainstay of tumor therapy

However, the possibility of infusion reactions and the burden of IV administration in hospitals or infusion centers and the risk of infection may make alternative dosing intervals an attractive option for patients and clinicians

The draft new guideline points out a method based on the population pharmacokinetics (pop-PK) model to support the approved alternative dosing regimens for PD-1 or PD-L1 blocking antibodies

The sponsor shall ensure that the alternative dosing regimen based on pop-PK applies for the use of the regimen used to prove effectiveness in clinical trials as the reference dosing regimen

For sponsors who plan to use the pop-PK strategy to support the submission of alternative dosing regimens, the FDA encourages early interaction and uses model-informed drug development matching meeting pilot programs when needed

The draft guideline outlines the information that should be included in the conference package, including relevant background information, a summary of the safety and effectiveness of the dose-effect relationship, simulation strategies and plans, and specific issues related to the proposed strategy

Finally, the draft guidelines set out a list of documents that should be included in the application materials for the approval of the alternative dosing regimen