ARTICLE | Regulation

Biotechs seek clarity on dose optimization

Stakeholders call for more detail on when and how to conduct dose optimization, in comments on FDA guidance

March 23, 2023 8:41 PM UTC

FDA’s dose-optimization requirements for cancer therapies are sure to shake up clinical trial designs and clinical development strategies, and companies are calling for more clarity on how exactly the processes will change.

In public comments submitted in response to FDA’s draft guidance on dose optimization for oncology therapies, which was released in January, representatives from biotech companies and the NIH raised questions about where the dose optimization steps should be built into the clinical development process, how optimized doses should be established for combination regimens, and whether the guidance applies to rare and pediatric cancers...