Getting the Dose Right: Optimizing Dose Selection Strategies in Oncology – An FDA-ASCO Virtual Workshop
May 3 - 5, 2022
- May 3 - 5, 2022
- - ET
- - ET
- Organized By:
- Sponsored By:
Registration required to attend: https://www.surveymonkey.com/r/2022DosingWorkshop
Current strategies for determining the recommended dose(s) of anticancer agents for evaluation in registration trials are often outdated and based on a historical drug development paradigm developed for cytotoxic chemotherapies. For cytotoxic chemotherapies, higher doses of the drug were thought to have greater antitumor activity. Dose selection was based on exposing small groups of patients to increasing doses and observing them for life-threatening toxicities to determine the maximum tolerated dose. Patients typically received cytotoxic chemotherapies for a short period of time. In contrast, most anticancer agents currently in development are targeted therapies, many of which are oral drugs. Higher doses of targeted therapies may not have greater antitumor effects, and patients may stay on these therapies for long periods of time, increasing the importance of tolerability. New approaches to optimize doses of targeted anticancer agents are needed.
In February 2021, American Society of Clinical Oncology (ASCO) and the U.S. Food and Drug Administration (FDA) cosponsored a workshop on oral adherence. A primary barrier to adherence identified was that labeled doses may be higher than necessary to achieve efficacy and have poor tolerability for patients. A strategy identified to improve adherence was to pursue dose optimization strategies that maintain efficacy while minimizing toxicity.
In this follow-on workshop, the FDA and ASCO will discuss research and clinical challenges for dose optimization and highlight strategies to improve dose optimization for anticancer agents.
- Provide a forum for open discussion among academia, industry, regulatory agencies, and patient groups about anticancer agent dose optimization.
- Discuss how to apply nonclinical, clinical pharmacology, clinical, and statistical evaluations to optimize the dose of anticancer agents.
- Discuss benefits and challenges related to pre- and post-marketing dose optimization trials.
- Discuss clinician and patient factors that impact participation in pre- and post-marketing dose optimization trials.
- Background Materials:
ASCO: Nicole Jenkins Nicole.Jenkins@asco.org
|Getting the Dose Right FDA ASCO Workshop Agenda||pdf (173.22 KB)|
|Getting the Dose Right FDA ASCO Workshop Agenda||pdf (186.95 KB)|
|Getting the Dose Right Bios Day 1||pdf (552.50 KB)|
|Getting the Dose Right Bios Day 2||pdf (583.81 KB)|