We wish to applaud the sentiments expressed in the recent article in The Cancer Letter titled “Oncologists, advocates, FDA call for an end to MTD and ‘more is better’ era in cancer drug dosing,” but also raise several concerns to be addressed as this initiative moves forward.
Getting the dose right is not a mere formality but a fundamentally important first step that can mean the difference between success and failure of a drug development program, Richard Pazdur, director of the FDA Oncology Center of Excellence, said at a workshop focused on the issue of dose optimization.
For decades, pinpointing the highest dose of a drug that cancer patients could tolerate was the first step investigators were required to take before moving into phase II and III clinical trials.
As more targeted cancer therapies hit the market, the maximum tolerated dose approach to cancer drug development no longer makes sense, said Brian Booth, director of FDA’s Division of Cancer Pharmacology I, at the April 21 meeting of the FDA Oncologic Drugs Advisory Committee.
