Recently I was honored to serve on a panel at the Friends of Cancer Research Annual Meeting. The topic of our panel was drug optimization. The FDA is changing the paradigm for clinical trials to report something that is referred to as the "Optimum Tolerated Dose" changing from the former accepted requirement of reporting only the "Maximum Tolerated Dose." The MTD as it is referred to is the highest dose that can be tolerated with "acceptable side effects". The Optimum dose however, would be reported as the dose that shows efficacy with minimum harms. This is a game changer for patients whose cancer will respond to the drug but are too sick or want better quality of life during treatment but cannot tolerate the MTD. Metastatic patients will greatly benefit from this change as most will remain on the drug for the rest of their lives or until the drug stops working. You can view the discussion on the attached link.https://www.youtube.com/watch?v=_cihaBVfNBE
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