FDA on breakthrough therapy requests by therapy area 2019

This statistic displays the share of breakthrough therapy requests to the FDA by therapeutic area, in the United States, as of 2019. As of end-September of that year, 26 percent of requests for breakthrough therapies came from the oncology area. The FDA recommends that submissions for breakthrough therapy designations should be made prior to phase III.

Distribution of FDA breakthrough therapy requests by therapy area in 2019

Percentage of breakthrough therapy requests
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Release date

December 2019


Worldwide, United States

Survey time period

as of September 30, 2019

Supplementary notes

FDA: Food and Drug Administration.

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Statistics on "Oncology"

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