Carfilzomib

Drug Profile

Carfilzomib

Alternative Names: Kyprolis; ONO-7057; PR-171

Latest Information Update: 10 Sep 2017

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At a glance

  • Originator Proteolix
  • Developer Dana-Farber Cancer Institute; Ohio State University Comprehensive Cancer Center; Onyx Pharmaceuticals; Phoenix Children's Hospital; Roswell Park Cancer Institute; The Innovative Therapies for Children with Cancer; Therapeutic Advances in Childhood Leukemia & Lymphoma; University of Alabama at Birmingham; University of Birmingham; University of California, Davis; University of Rochester; University of Texas M. D. Anderson Cancer Center
  • Class Antineoplastics; Epoxy compounds; Oligopeptides; Small molecules
  • Mechanism of Action Proteasome inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Multiple myeloma; Waldenstrom's macroglobulinaemia
  • New Molecular Entity Yes
  • Available For Licensing Yes - Multiple myeloma

Highest Development Phases

  • Marketed Multiple myeloma
  • Phase II Mantle-cell lymphoma; Prostate cancer; Renal cell carcinoma; Waldenstrom's macroglobulinaemia
  • Phase I/II Acute lymphoblastic leukaemia; Diffuse large B cell lymphoma; Peripheral T-cell lymphoma; Small cell lung cancer; Solid tumours
  • Phase I Leukaemia; Lymphoid leukaemia
  • No development reported Systemic lupus erythematosus

Most Recent Events

  • 30 Aug 2017 US FDA sets April 30, 2018 as PDUFA date for sNDA for Multiple myeloma
  • 30 Aug 2017 US FDA accepts sNDA for carfilzomib for Multiple myeloma for review
  • 30 Aug 2017 Post-hoc analysis of efficacy and adverse events data from a phase III ENDEAVOR trial in Multiple myeloma released by Amgen
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