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January 2017

Minimal Residual Disease as a Potential Surrogate End Point—Lingering Questions

Author Affiliations
  • 1Office of Hematology and Oncology Products, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland
JAMA Oncol. 2017;3(1):18-20. doi:10.1001/jamaoncol.2016.3112

In the treatment of multiple myeloma (MM), there have been important advances in recent decades. The introduction of new therapeutics, the use of high-dose therapy, and better supportive care have translated into longer progression-free survival (PFS), overall survival (OS) times, and higher response rates.1 For example, in a recent phase 3 randomized trial2 evaluating lenalidomide and dexamethasone with or without daratumumab, the reported overall response rate was 93%. Given these improvements, there has been interest in the development of surrogate end points to expedite drug development.

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