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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: 21 Dec 2019

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At a glance

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

  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Multiple myeloma

Most Recent Events

  • 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)
  • 14 Jan 2020 Janssen anticipates approval from the US FDA for BLA for daratumumab in Multiple myeloma (Second-line therapy or greater) in 2020 (SC)
  • 07 Dec 2019 Interim efficacy, safety and pharmacokinetic data from a phase III COLUMBA trial in multiple myeloma presented at the 61st Annual Meeting and Exposition of the American Society of Hematology (ASH-Hem-2019)
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