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Daratumumab/hyaluronidase - Janssen Biotech

Drug Profile

Daratumumab/hyaluronidase - Janssen Biotech

Alternative Names: DARA-PH20; DARA-SC; daratumumab and hyaluronidase-fihj; Daratumumab subcutaneous - Janssen Biotech; DARZALEX FASPRO; DARZALEX SC; DARZALEX-SC; Darzquro; Recombinant human hyaluronidase-based subcutaneous daratumumab

Latest Information Update: 04 Jun 2024

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At a glance

  • Originator Janssen Biotech
  • Developer Janssen Research & Development; Johnson & Johnson Innovative Medicine
  • Class Antineoplastics; Immunotherapies; 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 - Amyloid light-chain amyloidosis
  • New Molecular Entity No

Highest Development Phases

  • Marketed Amyloid light-chain amyloidosis; Multiple myeloma
  • Phase II Precursor T-cell lymphoblastic leukaemia-lymphoma

Most Recent Events

  • 18 Apr 2024 Janssen Research & Development completes a phase II clinical trials in Multiple myeloma (Combination therapy) in France, United Kingdom, Spain, Japan, Israel, Czech Republic, Brazil, USA (SC) (NCT03412565)
  • 30 Jan 2024 Johnson & Johnson files sBLA for treatment of patient with Multiple myeloma in USA
  • 30 Jan 2024 Efficacy data from a phase III PERSEUS trial in Multiple myeloma released by Johnson and Johnson
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