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Daratumumab/hyaluronidase - Janssen Biotech

Drug Profile

Daratumumab/hyaluronidase - Janssen Biotech

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

Latest Information Update: 18 Feb 2020

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At a glance

  • Originator Janssen Biotech
  • Developer Janssen Biotech; Janssen Pharmaceuticals; Janssen Research & Development
  • 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.

  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Multiple myeloma

Most Recent Events

  • 24 Feb 2020 Janssen intends to submit sBLA and MAA submission in Multiple myeloma (Combination therapy, Second-line therapy or greater) in year 2020
  • 11 Feb 2020 Janssen Research & Development initiates an pre-approval expanded-access programme for patients unable to receive intravenous daratumumab (NCT04264884)
  • 14 Jan 2020 Janssen anticipates approval from the EMA for extension application submitted for daratumumab in Multiple myeloma (Second-line therapy or greater) in 2020 (SC)
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