Search Orphan Drug Designations and Approvals
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Generic Name: | Bispecific T-cell engager (BiTE) containing two single-chain variable fragment (scFv) domains directed against the B cell maturation antigen (BCMA) surface receptor on tumor cells and the cluster of differentiation 3 (CD3) receptor on T-cells |
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Date Designated: | 02/08/2019 |
Orphan Designation: | Treatment of multiple myeloma |
Orphan Designation Status: | Designated |
FDA Orphan Approval Status: | Not FDA Approved for Orphan Indication |
Sponsor: |
Amgen, Inc. One Amgen Center Drive Thousand Oaks, California 91320 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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