In September, the Food and Drug Administration (FDA) and the American Society of Clinical Oncology (ASCO) are holding a free virtual workshop on the topic of dose optimization, a critical issue in oncology and in improving the quality of life for patients with cancer. In early phase clinical trials, the focus is usually on identifying the maximum tolerated dose and little effort is spent on identifying the optimal dose throughout drug development. Drugs are usually approved with recommended starting doses based on the maximum tolerated dose and frequently cause toxicity that can impact quality of life and in rare cases lead to emergency care, hospitalization, and subsequent dose reduction and delay in treatment.

This timely FDA-ASCO workshop will bring together thought leaders and others from academia, industry, regulatory agencies, and patient groups to discuss challenges and opportunities to improve dose selection for patients, specifically for use of combination therapies.

The event:
Getting the Dose Right: Optimizing Dosage Selection Strategies in Combination Cancer Therapies, an FDA-ASCO Workshop
Virtual, September 6-7, 2023 (1 pm – 4:45 pm ET each day)
Learn more and register to attend the workshop.

ASCO is committed to advancing the care of patients and addressing barriers to better outcomes. Drawing on information and ideas discussed at an FDA-ASCO cosponsored workshop held in 2021, the organizations issued a call to action emphasizing the importance of dose optimization on oral cancer therapy adherence and presenting an action plan for improvement. In addition, ASCO was awarded $11 million in research funding by the Patient-Centered Outcomes Research Institute (PCORI) to study oral drug dosing strategies in older adults with metastatic breast cancer receiving CDK4/6 inhibitors.

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