Kyprolis FDA Approval History
Last updated by Judith Stewart, BPharm on Jan 27, 2021.
FDA Approved: Yes (First approved July 20, 2012)
Brand name: Kyprolis
Generic name: carfilzomib
Dosage form: Injection
Company: Amgen Inc.
Treatment for: Multiple Myeloma
Kyprolis (carfilzomib) is a proteasome inhibitor used for the treatment of patients with multiple myeloma.
- Kyprolis is indicated:
- for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with
- Lenalidomide and dexamethasone; or
- Dexamethasone; or
- Daratumumab and dexamethasone; or
- Daratumumab and hyaluronidase-fihj and dexamethasone; or
- Isatuximab and dexamethasone.
- as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.
Development timeline for Kyprolis
| Date | Article |
|---|
| Aug 20, 2020 | Approval FDA Approves New Kyprolis (carfilzomib) Combination Regimen with Darzalex (daratumumab) and Dexamethasone in Both Once- And Twice-Weekly Dosing Regimens |
| Oct 1, 2018 | Approval FDA Approves Kyprolis (carfilzomib) Once-Weekly Kd70 Regimen for Relapsed or Refractory Multiple Myeloma |
| Jan 21, 2016 | Approval FDA Approves Kyprolis (carfilzomib) Combination Therapy for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma |
| Jul 24, 2015 | Approval FDA Approves Kyprolis (carfilzomib) for Combination Treatment of Patients with Relapsed Multiple Myeloma |
| Jul 20, 2012 | Approval FDA Approves Kyprolis (carfilzomib) for Patients with Advanced Multiple Myeloma |
| Jun 21, 2012 | Onyx Pharmaceuticals' Kyprolis Receives Positive Vote from Oncologic Drugs Advisory Committee (ODAC) |
| Jun 19, 2012 | Onyx Pharmaceuticals to Hold Conference Call on June 20, 2012 to Discuss FDA Advisory Committee Recommendation for Kyprolis |
| Apr 27, 2012 | Onyx Pharmaceuticals Announces FDA Advisory Committee to Review Carfilzomib for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma |
| Nov 29, 2011 | Onyx Pharmaceuticals Announces FDA Acceptance of New Drug Application for Carfilzomib for the Treatment of Relapsed and Refractory Multiple Myeloma |
| Oct 12, 2011 | Onyx Pharmaceuticals Submits New Drug Application for Carfilzomib in Relapsed and Refractory Multiple Myeloma |
| Oct 8, 2010 | Onyx Pharmaceuticals Provides Status Update on Carfilzomib |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medical Disclaimer
