• Jiaxi Zhou, Jonathon Vallejo, Paul Kluetz, Richard Pazdur, Tamy Kim, Patricia Keegan, Ann Farrell, Julia A Beaver, and Rajeshwari Sridhara.
• Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration.
• J. Natl. Cancer Inst. 2019 May 1; 111 (5): 449-458.

BackgroundWe previously conducted an overview of oncology products reviewed by the Office of Oncology Drug Products in the Center for Drug Evaluation and Research at the US Food and Drug Administration for marketing approval and the regulatory actions taken during July 2005 to December 2007. There is a need to understand if the changes in the laws, regulations, and the organization that occurred after 2007 had any impact on the regulatory drug approvals. We present a detailed overview of hematology and oncology products reviewed by Office of Oncology Drug Products and Office of Hematology and Oncology Drug Products.MethodsWe identified all oncology-hematology applications that were submitted to the US Food and Drug Administration from January 1, 2008 through December 31, 2016, and reviewed the approval actions taken.ResultsDuring the study period, the Office of Hematology and Oncology Products approved 239 applications that supported 260 new indications. Of the 239 applications approved, 141 were approved via priority review and 98 were approved via standard review. Fifty-three of these applications were granted accelerated approval, 29 were converted from accelerated approval to regular approval, and 157 received regular approval. Since its promulgation in 2013, breakthrough designation status has been granted to 25.7% of applications. A variety of endpoints were used to support these approvals.ConclusionDuring the study period, despite changes in the regulations and organization, the Office of Hematology and Oncology Products consistently utilized regulatory mechanisms that expedite the development and approval of promising oncology and hematology drug products resulting in the approval of 260 new indications.Published by Oxford University Press 2018.

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