The US Food and Drug Administration (FDA) this week finalized guidance detailing how sponsors of programmed cell death receptor-1 (PD-1) and programmed cell death-ligand 1 (PD-L1) drugs can support alternative dosing regimens for such drugs using pharmacokinetic (PK)-based modeling and simulation.
Notably, the population-PK-based approach detailed in the final guidance can be used to support new dosing regimens in the pre- and post-approval settings.
“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,” FDA explains…
