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Vusolimogene oderparepvec - Replimune

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Drug Profile

Vusolimogene oderparepvec - Replimune

Alternative Names: Recombinant Herpes Simplex Virus Type 1 - hGM CSF/GALV-GP-R-; RP 1

Latest Information Update: 31 Oct 2025

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At a glance

  • Originator Replimune
  • Developer Bristol-Myers Squibb; Regeneron Pharmaceuticals; Replimune
  • Class Antineoplastics; Gene therapies; Granulocyte-macrophage colony-stimulating factors; Immunotherapies; Oncolytic viruses
  • Mechanism of Action Cell death stimulants; Immunologic cytotoxicity
  • 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 Malignant melanoma
  • Phase II Non-small cell lung cancer; Skin cancer; Solid tumours; Squamous cell cancer
  • Phase I/II Triple negative breast cancer

Most Recent Events

  • 20 Oct 2025 FDA assigns PDUFA action date of 10 April 2026 for vusolimogene oderparepvec for Malignant melanoma (Combination therapy, Late-stage disease, Second-line therapy or greater)
  • 20 Oct 2025 The US FDA accepts the resubmission of the Biologics License Application (BLA) for Vusolimogene oderparepvec in Melanoma
  • 19 Oct 2025 Efficacy and adverse events data from a phase I/II trial in Solid tumours released by Replimune

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