Drug Profile


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

Latest Information Update: 18 Sep 2017

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At a glance

  • Originator Genmab
  • Developer Boston Medical Center; Bristol-Myers Squibb; Genentech; Genmab; Janssen Biotech; Janssen Research & Development
  • Class Antineoplastics; Monoclonal antibodies
  • Mechanism of Action Apoptosis stimulants; 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; Prostate cancer; T cell lymphoma
  • Phase I/II Amyloid light-chain amyloidosis; Non-small cell lung cancer; Solid tumours
  • No development reported Chronic lymphocytic leukaemia

Most Recent Events

  • 24 Aug 2017 Interim efficacy and adverse events data from the phase III ALCYONE trial in Multiple myeloma released by Genmab
  • 11 Aug 2017 Janssen Pharmaceutical plans a phase I trial for Multiple myeloma (Second-line therapy or greater) in Japan (NCT03242889)
  • 10 Aug 2017 Phase-I clinical trials in Multiple myeloma (Second-line therapy or greater) in Japan (SC) (NCT03242889)
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