US FDA Cancer Drug Dosage Optimization Guidance Will Increase Exposure To Ineffective Agents, NCI Says

07 Apr 2023

Draft recommendations would lead to enrolling additional patients on multiple dose levels to assess activity before clinical effectiveness has been established, National Cancer Institute says; industry cites need for flexibility in recommending randomized studies of multiple dosages and questions utility of PRO data in early dose finding studies.

Population growth — National Cancer Institute says new FDA draft guidance will subject a substantial number of additional patients to dose optimization studies of ineffective or non-viable agents. • Source: Shutterstock

The US Food and Drug Administration’s draft recommendations on cancer drug dosage optimization run the risk of exposing many more patients to drugs and dosages that ultimately prove clinically ineffective, stakeholders said.

In comments on the January draft guidance, several stakeholders, including the US National Cancer Institute, suggest conducting extensive dose optimization...