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Deconstructing the FDA’s Guidance on Optimizing the Dosage of Prescription Drugs and Biological Products
- 1. DECONSTRUCTINGTHEFDA’S GUIDANCEONOPTIMIZINGTHE DOSAGEOFPRESCRIPTION DRUGSANDBIOLOGICAL PRODUCTS WEBINAREXCLUSIVE APRIL 5, 2023 12:30 PM PDT 3:30 PM EDT 8:30 PM GMT
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- 3. Have questions about todays presentation? Click on the Questions panel to interact with the presenters Having issues with todays presentation? Try Dialing in! TO USE YOUR TELEPHONE: You must select "Use Telephone" after joining and call in using the numbers below. United States: +1 (415) 655-0060 Access Code: 679-151-637 Audio PIN: Shown after joining the webinar
- 5. What Does FDA’s Project Optimus Have to Say About This? • Project Optimus is designed to challenge current paradigms in dose selection for oncology
- 6. • Ultimately • Reforming dose optimization and selection in oncology • Why? Treatment durations are long in oncology • Risk of higher-than-necessary toxicity is not rare, but common
- 7. Oncology and Cytotoxicity • Oncology has existed on the backs of cytotoxic agents, such as platins • These drugs kill rapidly-dividing cells, often indiscriminately • The higher the dose, the greater kill of cancer cells • …and non-cancerous cells • Hence Dose-Limiting Toxicity (DLT)
- 8. Paradigm of Dosing with Cytotoxic Drugs • Regimen determined by physiological response • Cycles, reductions, holidays, interruptions
- 9. And cytotoxicities aren’t the only burden for patients Huff, C. (2023). STAT. https://www.statnews.com/2023/04/10/cancer-treatment-end-of-life-time-toxicity
- 10. Simulated Phase 1 Study Design • 3x3 dose escalation • Assess for safety and up to Maximum Tolerated Dose (MTD)
- 11. Dose-Response Curves and Patient Tx • Hypothetical dose-response curve
- 12. Comparison of Dose-Response Curves • Biology is curvilinear!
- 13. Based on the type of cytotoxic agent, dose-response toxicities necessarily differ. Adding to that, efficacy isn’t linear, either! Toxicity Efficacy Finding the right dose, where we can maximize the balance of efficacy WITH limiting toxicity for the patient MTD is not the optimum biologic dose! It’s very likely that saturation (receptor) dose is lower than the MTD!
- 16. • Why? • Selecting an optimum dose within oncology requires good data from clinical trials from multiple dose levels in Phase II & III studies • Comparative assessments of dosing regimes, comparators • Look for statistical significance • Modernized therapies, including ADCs, immunotherapies, etc., have saturation limits which often can be below the MTD; So going to MTD is the wrong approach • Maximizing efficacy, minimizing toxicity and side effects
- 17. Q&A /in/rayvonnecarter/ HumanResources Today.com Biopharmaceutical Executive & Healthcare Futurist Dr. Ben Locwin /in/ben-locwin/ td.org/user/content/BenLocwin