FDA Breakthrough Therapy Designation: Another For Multiple Myeloma
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:
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