FDA-AACR PUBLIC WORKSHOP ON OPTIMIZING DOSAGES FOR ONCOLOGY DRUG PRODUCTS: QUANTITATIVE APPROACHES TO SELECT DOSAGES FOR CLINICAL TRIALS
February 15, 2024, 8 a.m. – 5 p.m. | February 16, 2024, 8 a.m. – 1 p.m.
Grand Hyatt Washington | 1000 H Street, NW | Washington, D.C. 20001
Slide presentations and recordings from this event are available below.
agenda speaker bios background blogThe U.S. Food and Drug Administration (FDA) Office of Clinical Pharmacology and the American Association for Cancer Research (AACR) are collaborating on a day-and-a-half long hybrid public workshop to discuss dosage optimization for oncology drug products. This follows previous FDA-AACR workshops in 2015, 2016, and 2017 on dosage optimization.
Historically, dose-finding trials for oncology drugs have been primarily designed to determine the “Maximum Tolerated Dose” (MTD), which is determined by gradually increasing the dose in a small number of patients at each dose for short periods of time until it is too toxic for patients. This strategy was developed for cytotoxic chemotherapy. However, this approach may lead to poorly tolerated dosages for modern oncology drugs with novel mechanisms of action, including targeted therapies and immunotherapies. Continued reliance on the MTD may lead to unnecessary side effects without added benefits for patients.
FDA and AACR strongly encourage a more holistic approach that leverages all available nonclinical and clinical data. In January 2023, FDA published a new draft guidance intended to help sponsors identify an optimized dosage(s) for oncology products. This workshop aims to: discuss best practices and methods for evaluating all nonclinical and clinical data, and incorporating modeling and simulation to identify optimized dosages; consider innovative clinical trial designs; and highlight ongoing efforts in academia, industry, and regulatory agencies. These changes may require a culture change in drug development and, in some cases, additional investments earlier in drug development. However, strategies to improve dosage selection hold great promise for improved long-term patient outcomes.
program
Day 1
- Session 1: Selecting Dosages for Dose-Escalation Portion of First-In-Human Trials
- Session 1A: Utilizing Nonclinical Data and Modeling to Support Dosage Selection for First in Human Trials
- Moderator: Hao Zhu, PhD, U.S. Food and Drug Administration
- Session 1A: Utilizing Nonclinical Data and Modeling to Support Dosage Selection for First in Human Trials
- Session 1B: Alternative Designs for Dose-Finding Trials: Ending Reliance on Short-Term Safety
- Moderator: Patricia LoRusso, DO, PhD (hc), FAACR, Yale Cancer Center
- Session 2: Selecting Dosages for Additional Exploration Based On Nonclinical and Early Clinical Data
- Session 2A: Evaluating and Modeling All Early Data to Select Recommended Phase II Dose
- Moderator: Lanre Okusanya, PharmD, U.S. Food and Drug Administration
- Session 2A: Evaluating and Modeling All Early Data to Select Recommended Phase II Dose
- Session 2B: Novel Trial Designs to Enhance Dose-Selection Decision Making
- Moderator: Timothy Yap, MD, PhD, MD Anderson Cancer Center
Day 2
- Session 3: Selecting Dosages for Registrational Trials
- Session 3A: Considering the Totality of Efficacy and Safety Data to Aide Registrational Trial Designs
- Moderator: Stacy Shord, PharmD, U.S. Food and Drug Administration
- Session 3A: Considering the Totality of Efficacy and Safety Data to Aide Registrational Trial Designs
- Session 3B: Implementing Seamless and Adaptive Registrational Trial Designs
- Moderator: Geoffrey Oxnard, MD, LOXO@Lilly
- Closing Panel Discussion: Optimizing Project Optimus
- Moderator: Patricia LoRusso, DO, PhD (hc), FAACR, Yale Cancer Center
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