Drug Profile


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

Latest Information Update: 20 May 2017

Price : $50

At a glance

  • Originator Genmab
  • Developer Boston Medical Center; Genentech; Genmab; Janssen Biotech; Janssen Research & Development
  • 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 - Multiple myeloma; Follicular lymphoma; Mantle-cell lymphoma; Diffuse large B cell lymphoma
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Multiple myeloma
  • Phase II Diffuse large B cell lymphoma; Follicular lymphoma; Mantle-cell lymphoma; Myelodysplastic syndromes; T cell lymphoma
  • Phase I/II Amyloid light-chain amyloidosis; Non-small cell lung cancer
  • No development reported Chronic lymphocytic leukaemia

Most Recent Events

  • 28 Apr 2017 Launched for Multiple myeloma (Combination therapy, Second-line therapy or greater) in United Kingdom (IV)
  • 28 Apr 2017 Registered for Multiple myeloma (Combination therapy, Second-line therapy or greater) in Liechtenstein, Norway, Iceland and European Union (IV)
  • 28 Apr 2017 Janssen and European Myeloma Network plan the randomised, open-label, multicenter phase III APOLLO trial (MMY3013) for Multiple myeloma (Combination therapy with pomalidomide and dexamethasone, Second-line therapy or greater) in Europe in Q2 2017
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