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Trastuzumab biosimilar - Tanvex Biopharma

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Drug Profile

Trastuzumab biosimilar - Tanvex Biopharma

Alternative Names: TX-05

Latest Information Update: 15 Jul 2024

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At a glance

  • Originator Tanvex BioPharma
  • Class Antineoplastics; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; ERBB 2 receptor antagonists
  • Orphan Drug Status

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

    No
  • New Molecular Entity No

Highest Development Phases

  • Preregistration HER2 positive breast cancer

Most Recent Events

  • 06 Jul 2024 Tanvex Biopharma resubmits the BLA for trastuzumab biosimilar to the US FDA
  • 03 Jun 2022 Efficacy and adverse events data from a phase III trial in Breast cancer presented at the 58th Annual Meeting of the American Society of Clinical Oncology (ASCO-2022)
  • 08 Mar 2022 Tanvex Biopharma completes a phase III extension trial in Her2 positive Breast cancer (Early-stage disease, Neoadjuvant therapy, In adults, In the elderly) in Hungary, Belarus, Chile, Georgia, India, Mexico, Peru, Philippines, Russia, Ukraine and Bulgaria (IV) (EudraCT2018-000236-97) (NCT04109391)

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