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Comment & Response
September 2018

Clarification of the FDA Accelerated Agnostic Approval of Pembrolizumab and the Opportunities Arising From the Required Confirmatory Studies

Author Affiliations
  • 1Oncology Division, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina
JAMA Oncol. 2018;4(9):1299-1300. doi:10.1001/jamaoncol.2018.1709

To the Editor Prasad et al1 highlighted challenges related to the US Food and Drug Administration (FDA) accelerated approval of pembrolizumab use for patients with deficient mismatch repair gene expressing (dMMR) or microsatellite instability–high (MSI-H) solid tumors. It is important to clarify the accelerated approval basis and the opportunities resulting from the FDA-required confirmatory studies.