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FDA Breakthrough Therapy Designation: Another For Multiple Myeloma

May 19, 2014

Bristol-Myers Squibb (BMS) and AbbVie on May 19th receive the FDA Breakthrough Therapy Designation (BTD) for Elotuzumab. Elotuzumab is an investigational humanized monoclonal antibody that receives FDA Orphan Drug Designation (ODD) in September 2011 and EMA ODD in August 2012.

The BTD is for Elotuzumab in combination with Lenalidomide and Dexamethasone for the treatment of Multiple Myeloma (MM), for those who have received one or more prior therapies. The BTD is based on a randomized Phase II, open-label study, that is presented at the Annual Congress of the European Hematology Association (EHA) in 2013.

This is the 40th BTD announced by a sponsor company, the 4th BTD for BMS, the 2nd BTD for AbbVie, and the 2nd BTD for MM:

Num Drug Name Sponsor Companies
1 Daratumumab Genmab/Janssen
2 Elotuzumab BMS/AbbVie




FDA BTD Approval Chart

FDA BTD Statistics Chart.

Please Note: FDA Official Logo from FDA website.

Copyright © 2012-2014, Orphan Druganaut Blog. All rights reserved.

  1. Just before BMS revealed breakthrough status for Elotuzumab in r/r MM, the timeline for PFS results in the r/r MM Phase III was extended 3.5 more years? Originally 3-2014 was the anticipated primary results date, but now it’s 8-2017? Accrual was closed at all 211 sites by 11-2012. Was a late decision made to offer study drug to the control arm patients? I can’t think of any other explanation for this long delay during a Breakthrough Designation.

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