Drug Profile


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

Latest Information Update: 25 Mar 2017

Price : $50

At a glance

  • Originator Genmab
  • Developer 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
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

  • New Molecular Entity Yes

Highest Development Phases

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

Most Recent Events

  • 23 Feb 2017 CHMP recommends approval of extension of label for daratumumab for use in Multiple myeloma (Combination therapy, Second line therapy or greater) in European Union
  • 08 Feb 2017 Janssen withdraws prior to enrolment a phase II trial in Prostate cancer (First-line therapy, Neoadjuvant therapy) in USA (NCT03035357)
  • 01 Feb 2017 Phase-II clinical trials in Myelodysplastic syndromes (Second-line therapy or greater, In adults, In the elderly) in Spain (IV) (NCT03011034)
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top