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Kyprolis Approval History

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 indicated for the treatment of patients with multiple myeloma.

Development History and FDA Approval Process for Kyprolis

DateArticle
Oct  1, 2018Approval FDA Approves Kyprolis (carfilzomib) Once-Weekly Kd70 Regimen for Relapsed or Refractory Multiple Myeloma
Jan 21, 2016Approval FDA Approves Kyprolis (carfilzomib) Combination Therapy for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
Jul 24, 2015Approval FDA Approves Kyprolis (carfilzomib) for Combination Treatment of Patients with Relapsed Multiple Myeloma
Jul 20, 2012Approval FDA Approves Kyprolis (carfilzomib) for Patients with Advanced Multiple Myeloma
Jun 21, 2012Onyx Pharmaceuticals' Kyprolis Receives Positive Vote from Oncologic Drugs Advisory Committee (ODAC)
Jun 19, 2012Onyx Pharmaceuticals to Hold Conference Call on June 20, 2012 to Discuss FDA Advisory Committee Recommendation for Kyprolis
Apr 27, 2012Onyx Pharmaceuticals Announces FDA Advisory Committee to Review Carfilzomib for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma
Nov 29, 2011Onyx Pharmaceuticals Announces FDA Acceptance of New Drug Application for Carfilzomib for the Treatment of Relapsed and Refractory Multiple Myeloma
Oct 12, 2011Onyx Pharmaceuticals Submits New Drug Application for Carfilzomib in Relapsed and Refractory Multiple Myeloma
Oct  8, 2010Onyx Pharmaceuticals Provides Status Update on Carfilzomib

Further information

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