The toxicity associated with oncology therapies is the stuff of legend with clinicians and patients, and thus the U.S. FDA and manufacturers have been working to fine tune these dosing regimens. However, the FDA's Oncology Center of Excellence (OCE) includes a programmatic effort to optimize dosing regimens, which led to an editorial by FDA officials that calls on industry to consider whether the maximum tolerated dose paradigm is really the optimal approach to oncology drug development.