Daratumumab - Janssen Biotech

Drug Profile

Daratumumab - Janssen Biotech

Alternative Names: DARZALEX; Humanised anti-CD38 monoclonal antibody; HuMax-CD38; HuMax®-CD38 - Genmab; JNJ-54767414

Latest Information Update: 13 Aug 2018

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At a glance

  • Originator Genmab
  • Developer Boston Medical Center; Bristol-Myers Squibb; Dana-Farber Cancer Institute; Genentech; Genmab; Janssen Biotech; Janssen Research & Development; M. D. Anderson Cancer Center; Syros Pharmaceuticals
  • Class Antineoplastics; Monoclonal antibodies
  • Mechanism of Action Apoptosis stimulants; CD38 antigen inhibitors; Immunostimulants
  • Orphan Drug Status

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

    Yes - Follicular lymphoma; Multiple myeloma; Mantle-cell lymphoma; Diffuse large B cell lymphoma
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Multiple myeloma
  • Phase III Amyloid light-chain amyloidosis
  • Phase II Acute myeloid leukaemia; Diffuse large B cell lymphoma; Follicular lymphoma; Mantle-cell lymphoma; Myelodysplastic syndromes; Precursor B-cell lymphoblastic leukaemia-lymphoma; Precursor T-cell lymphoblastic leukaemia-lymphoma; Prostate cancer; T cell lymphoma; Waldenstrom's macroglobulinaemia
  • Phase I/II Solid tumours
  • Suspended Non-small cell lung cancer
  • No development reported Chronic lymphocytic leukaemia

Most Recent Events

  • 08 Aug 2018 Janssen Pharmaceutical files a sBLA application with the US FDA for approval of daratumumab split dosing regimen for Multiple myeloma
  • 08 Aug 2018 Janssen Pharmaceutical files a Type II Variation application with the European Medicines Agency (EMA) for approval of daratumumab split dosing regimen for Multiple myeloma
  • 27 Jul 2018 The Committee for Medicinal Products for Human Use of the EMA recommends approval of daratumumab for Multiple myeloma (Combination therapy, First line therapy, Newly diagnosed) in European Union
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