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Tisotumab vedotin - Genmab/Seagen

Drug Profile

Tisotumab vedotin - Genmab/Seagen

Alternative Names: HuMax-TF; HuMax-TF-ADC; Humax®-TF-ADC; TF-011-MMAE; Tisotumab vedotin-tftv - Genmab/Seagen; TIVDAK

Latest Information Update: 07 Feb 2024

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At a glance

  • Originator Genmab
  • Developer Genmab; Seagen; ZAI Lab
  • Class Antineoplastics; Auristatins; Drug conjugates; Immunotherapies; Immunotoxins; Monoclonal antibodies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; Mitosis inhibitors; Tubulin polymerisation inhibitors
  • Orphan Drug Status

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

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Cervical cancer
  • Phase II Fallopian tube cancer; Ovarian cancer; Peritoneal cancer; Solid tumours

Most Recent Events

  • 02 Feb 2024 Preregistration for Cervical cancer (Metastatic disease, Second-line therapy or greater, Recurrent) in European Union (IV)
  • 09 Jan 2024 FDA assigns PDUFA action date of (09/05/2024) for tisotumab vedotin (full approval) for Cervical cancer
  • 09 Jan 2024 The US FDA accepts sBLA seeking to convert the accelerated approval to full approval for tisotumab vedotin for Cevical cancer (Metastatic disease, Second-line therapy or greater) for review
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