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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: carfilzomib
Trade Name: Kyprolis
Date Designated: 01/18/2008
Orphan Designation: Treatment of multiple myeloma
Orphan Designation Status: Designated/Approved
Onyx Therapeutics, Inc.
249 East Grand Avenue
South San Francisco, California 94080
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: carfilzomib
Trade Name: Kyprolis
Marketing Approval Date: 07/20/2012
Approved Labeled Indication: Treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent and have demonstrated disease progression on or within 60 days of completion of the last therapy.
Exclusivity End Date: 07/20/2019 
Exclusivity Protected Indication* :  
2 Generic Name: carfilzomib
Trade Name: Kyprolis
Marketing Approval Date: 08/20/2020
Approved Labeled Indication: Treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with daratumumab and dexamethasone.
Exclusivity End Date: N/A  
3 Generic Name: carfilzomib
Trade Name: Kyprolis
Marketing Approval Date: 11/30/2021
Approved Labeled Indication: treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with daratumumab and hyaluronidase-fihj and dexamethasone
Exclusivity End Date: N/A  
4 Generic Name: carfilzomib
Trade Name: Kyprolis
Marketing Approval Date: 06/30/2022
Approved Labeled Indication: Treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with isatuximab and dexamethasone
Exclusivity End Date: N/A  
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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