Search Orphan Drug Designations and Approvals
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Generic Name: | carfilzomib | ||||||||||||||||
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Trade Name: | Kyprolis | ||||||||||||||||
Date Designated: | 01/18/2008 | ||||||||||||||||
Orphan Designation: | Treatment of multiple myeloma | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
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. |
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Marketing approved: |
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1 | Generic Name: | carfilzomib |
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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 |
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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 |
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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 |
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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 | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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