FDA finalizes PK-based dosing guidance for PD-1/PD-L1 inhibitors

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.