Drug Profile


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

Latest Information Update: 20 Jul 2017

Price : $50

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; 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 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

  • 17 Jul 2017 Merck Sharp & Dohme plans the phase II KEYNOTE-668 trial for Multiple myeloma (Combination therapy, Second-line therapy or greater) in USA, Canada, France, Israel, Norway, Spain and Sweden (IV) (NCT03221634)
  • 01 Jul 2017 Janssen initiates enrolment in a phase II trial in Multiple myeloma (Combination therapy, Newly diagnosed) in USA (IV) (NCT03004287)
  • 16 Jun 2017 The US FDA approves daratumumab for use in Multiple myeloma (Combination therapy, Second line therapy or greater) (In combination with pomalidomide and dexamethasone) in USA
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