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Trastuzumab duocarmazine - Byondis

Drug Profile

Trastuzumab duocarmazine - Byondis

Alternative Names: (vic-)trastuzumab-duocarmazine; Anti-HER2 ADC - Byondis; Jivadco; SYD-985; Trastuzumab vc-seco-DUBA; Trastuzumab-SYD980

Latest Information Update: 06 Dec 2023

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At a glance

  • Originator Synthon
  • Developer Byondis; Yale University School of Medicine
  • Class Antineoplastics; Bacterial toxins; Cytostatic antibiotics; Drug conjugates; Immunoconjugates; Monoclonal antibodies; Small molecules
  • Mechanism of Action Alkylating agents; Antibody-dependent cell cytotoxicity; DNA inhibitors; ERBB 2 receptor antagonists
  • Orphan Drug Status

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

  • New Molecular Entity Yes
  • Available For Licensing Yes - Cancer

Highest Development Phases

  • Preregistration HER2 positive breast cancer
  • Phase II Endometrial cancer
  • No development reported Gastric cancer; Gynaecological cancer; Non-small cell lung cancer; Solid tumours

Most Recent Events

  • 20 Oct 2023 Efficacy and adverse events data from the phase-III TULIP trial in Breast cancer presented at the 48th European Society for Medical Oncology Congress (ESMO-20023)
  • 28 Sep 2023 No recent reports of development identified for phase-I development in Solid-tumours(Combination therapy, Late-stage disease, Metastatic disease, Second-line therapy or greater) in Netherlands (IV, Infusion)
  • 12 Sep 2023 Regulatory submission withdrawn for HER2-positive-breast-cancer (Inoperable/Unresectable, Late-stage disease, Metastatic disease, Second-line therapy or greater) in European Union (IV)
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