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Drugs granted breakthrough therapy designation (BTD) by the US Food and Drug Administration (FDA). Drugs may be listed more than once since breakthrough therapy can be awarded for multiple indications.
A breakthrough therapy designation can be assigned to a drug if "it is a drug which is intended alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition" and if the preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as ...
This list may not reflect recent changes. ... List of drugs granted breakthrough therapy designation; List of designer drugs; 0–9. List of drugs: 1–9; A.
Breakthrough Therapy Designation was created for drugs that may be significantly better treatments for serious diseases or conditions. [8] On November 13, 2013, the FDA approved obinutuzumab (trade name Gazyva) by Hoffmann-La Roche [9] for chronic lymphocytic leukemia making it the first drug to receive the breakthrough therapy designation.
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The FDA grants Breakthrough Therapy designation to Bristol-Myers Squibb's (BMY) Orencia for the prevention of moderate-to-severe acute GvHD in hematopoietic SCT from unrelated donors.
The Breakthrough Therapy Designation was part of the last year's FDA Safety and Innovation Act, which is supposed to speed up development review time -- potentially requiring less data for ...
Fast track is a designation by the United States Food and Drug Administration (FDA) of an investigational drug for expedited review to facilitate development of drugs that treat a serious or life-threatening condition and fill an unmet medical need. Fast track designation must be requested by the drug company.