|
On August 8, 2024, FDA announced the availability of a final guidance for industry entitled Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases, replacing the January 2023 draft guidance on this topic. This final guidance describes the FDA recommendations for identifying an optimized dosage(s) for human prescription drugs or biological products for the treatment of oncologic diseases during clinical development and prior to submitting an application for approval of a new indication and usage.
Dosage optimization prior to approval is recommended because delaying until after approval may result in large numbers of patients being exposed to a poorly tolerated dosage or one without maximal clinical benefit. Furthermore, conducting clinical trials to compare multiple dosages may be challenging to complete once a drug is approved for a given indication.
FDA recognizes that the best approach to determining the optimized dosage(s) for a specific drug development program depends upon a variety of factors, including but not limited to, the drug class, proposed indicated patient population, and prior knowledge about the drug that is pertinent to dosing. Sponsors are therefore strongly encouraged to discuss their plans for dosage optimization with FDA during formal meetings, including early in clinical development. Sponsors may also consider the Model-Informed Drug Development (MIDD) paired meeting program, if appropriate.
The guidance provides the recommendation regarding collection of relevant data and trial design to identify optimized dosages, specifically addressing: (1) clinical pharmacokinetics, pharmacodynamics and pharmacogenomics, (2) trial designs to compare multiple dosages, (3) safety and tolerability, (4) drug formulation and (5) subsequent indications and usages
|
