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Daratumumab - Janssen Biotech

Drug Profile

Daratumumab - Janssen Biotech

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

Latest Information Update: 16 Nov 2019

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At a glance

  • Originator Genmab
  • Developer Amgen; Boston Medical Center; Bristol-Myers Squibb; Dana-Farber Cancer Institute; French Innovative Leukemia Organisation; Genentech; Genmab; Janssen Biotech; Janssen Research & Development; M. D. Anderson Cancer Center; Syros Pharmaceuticals
  • Class Antineoplastics; Monoclonal antibodies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; Apoptosis stimulants; Phagocyte stimulants; T lymphocyte stimulants
  • Orphan Drug Status

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

    Yes - Multiple myeloma; Mantle-cell lymphoma; Follicular 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; Chronic lymphocytic 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

Most Recent Events

  • 16 Nov 2019 Janssen completes enrolment in its phase III APOLLO trial (Combination therapy, Second-line therapy or greater) in Belgium, Czech Republic, Denmark, Germany, Greece, Italy, Netherlands, Serbia, Spain, Turkey (NCT03180736)
  • 30 Oct 2019 The Health Canada approves daratumumab for Multiple myeloma (Combination therapy, First-line therapy, Newly diagnosed) in Canada (IV)
  • 28 Oct 2019 No recent reports of development identified for phase-I development in Multiple-myeloma(Monotherapy, Second-line therapy or greater) in China (IV, Infusion)
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