Cancer Drug Dose Optimization Benefits Include Better Pivotal Trial Retention, Fewer Clinical Holds

03 Dec 2021

US FDA is asking oncology sponsors for randomized studies comparing at least two doses early in development; despite concerns about delaying approval, FDA and industry reps say approach will increase success of registrational trials and reduce likelihood of market withdrawal due to toxicity.

Quick sand — Basing a drug development program on a shaky dose is like building a house on quicksand, OCE director Richard Pazdur says. • Source: Alamy

The significant advantages of conducting more extensive dose-optimization studies early in oncology drug development will overcome industry and patient concerns about perceived delays in bringing new therapeutics to market, representatives from the US Food and Drug Administration, industry and patient community said.

At the Friends of Cancer Research annual meeting last month, a multi-stakeholder panel discussed the FDA Oncology Center of Excellence’s...