FDA Breakthrough Therapy Designation Chart

Updated :  01/29/15 for Breakthrough Therapy #60.  02/02/15 for Breakthrough Therapies #61 & #62.   02/06/15 for Breakthrough Therapy #63 (BMS’s September 2014 BTD for Opdivo (Nivolumab) that was missing).  02/23/15 for Breakthrough Therapy #64.  03/02/15 for Breakthrough Therapy #65 & #66.  04/06/15 for Breakthrough Therapy #67.  04/21/15 for Breakthrough Therapy #68.  05/06/15 for Breakthrough Therapy #69.  05/28/15 for Breakthrough Therapy #70.  06/04/15 for Breakthrough Therapy #71.

71 FDA Breakthrough Therapy Designations

The 71 Breakthrough Therapy Designations granted for drugs that have been identified by the sponsor companies (as of 06/04/15) are as follows:

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The Column in the Chart titled “Drug Name” contains the URL for the link to the Press Release announcing the FDA Breakthrough Therapy Designation for each drug.

The FDA doesn’t disclose information regarding sponsors who submitted requests for or who have been granted or denied breakthrough therapy designations. Per the FDA website,  “Breakthrough therapy designation requests are typically submitted to an IND, and the FDA cannot disclose the existence of an IND, or any submissions that have been submitted to the IND, unless it has previously been publicly disclosed or acknowledged per 21 CFR 312.130(a).”

References

FDA BTD Chart

FDA BTD Approval Chart

FDA BTD Statistics Chart.

Please Note: FDA Official Logo from FDA website.

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