Vusolimogene oderparepvec

Vusolimogene oderparepvec
Clinical data
Trade namesTudriqev
Other namesRP1, vusolimogene oderparepvec-wtpg
AHFS/Drugs.comtudriqev
License data
Routes of
administration		Intratumor injection
Drug classAntineoplastic
ATC code
  • None
Legal status
Legal status
Identifiers
CAS Number
UNII

Vusolimogene oderparepvec, sold under the brand name Tudriqev, is an anti-cancer medication used for the treatment of melanoma.[1] It is a genetically modified herpes simplex virus type 1 oncolytic virus that is injected directly into tumors.[1][2]

The most common non-laboratory adverse reactions include fatigue, pyrexia, infections, chills, musculoskeletal pain, nausea, diarrhea, injection site reaction, headache, cough, influenza like illness, rash, vomiting, pruritus, arthralgia, constipation, decreased appetite, dizziness, dyspnea, hemorrhage, edema, and abdominal pain.[2]

Vusolimogene oderparepvec was granted accelerated approval for medical use in the United States in August 2026.[2][3]

Medical uses

Vusolimogene oderparepvec is indicated in combination with nivolumab for the treatment of adults with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death receptor-1-blocking antibody-based regimen.[1][4]

Adverse effects

The US prescribing information includes warnings and precautions for accidental exposure, herpetic infection or reactivation, injection procedure complications, and immune-mediated events.[2]

The most common non-laboratory adverse reactions include fatigue, pyrexia, infections, chills, musculoskeletal pain, nausea, diarrhea, injection site reaction, headache, cough, influenza like illness, rash, vomiting, pruritus, arthralgia, constipation, decreased appetite, dizziness, dyspnea, hemorrhage, edema, and abdominal pain.[2]

Composition

Vusolimogene oderparepvec is an oncolytic herpes virus that was created by genetically engineering a strain of herpes simplex virus 1 (HSV-1) to express GM-CSF and a glycoprotein from the envelope of gibbon ape leukemia virus.[5]

History

The safety and efficacy of vusolimogene oderparepvec were evaluated in IGNYTE (NCT03767348), an open-label, multiregional, single-arm trial in 140 adults with stage IIIB, IIIC or IV unresectable advanced melanoma who experienced disease progression on at least eight consecutive weeks of prior anti-programmed death receptor-1-based therapy.[2] Of the 140 participants, 91 participants with at least one noninjected lesion were included in the efficacy-evaluable population.[2]

Society and culture

Vusolimogene oderparepvec was granted accelerated approval for medical use in the United States in August 2026.[2] Replimmune is obligated to conduct further clinical studies to ensure there is a benefit, and the FDA may withdraw the approval if the results are not good enough.[2].[2]

The US Food and Drug Administration (FDA) granted the application for vusolimogene oderparepvec, in combination with nivolumab, breakthrough therapy designation to Replimune.[2]

Names

Vusolimogene oderparepvec is the international nonproprietary name[6] and the United States Adopted Name.[7]

Vusolimogene oderparepvec is sold under the brand name Tudriqev.[2][8]

References

  1. ^ a b c d "Tudriqev (vusolimogene oderparepvec-wtpg) suspension for intratumor injection" (PDF). U.S. Food and Drug Administration (FDA).
  2. ^ a b c d e f g h i j k l "FDA grants accelerated approval to vusolimogene oderparepvec-wtpg in combination with nivolumab for melanoma". U.S. Food and Drug Administration (FDA). 6 August 2026. Retrieved 7 August 2026. Public Domain This article incorporates text from this source, which is in the public domain.
  3. ^ "FDA Approves New Engineered Viral Immunotherapy for Patients with Treatment-Resistant Advanced Melanoma" (Press release). U.S. Food and Drug Administration (FDA). 6 August 2026. Retrieved 7 August 2026. Public Domain This article incorporates text from this source, which is in the public domain.
  4. ^ "Tudriqev". U.S. Food and Drug Administration (FDA). 6 August 2026. Retrieved 7 August 2026. Public Domain This article incorporates text from this source, which is in the public domain.
  5. ^ Ma VT, Steimle AK, Patel JD, Burkey C, Moser JC, Javed A, et al. (July 2026). "Updates on intratumoral therapies in melanoma". Cancer. 132 (13) e70400. doi:10.1002/cncr.70400. PMC 13301002. PMID 42349466.
  6. ^ World Health Organization (2022). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 87". WHO Drug Information. 36 (1). hdl:10665/352794.
  7. ^ https://searchusan.ama-assn.org/usan/documentDownload?uri=/unstructured/binary/usan/vuslimogene-oderparepvec-.pdf
  8. ^ "Replimune Announces FDA Accelerated Approval of Tudriqev in Combination with Nivolumab for Unresectable Advanced Cutaneous Melanoma After Progression on an anti-PD-1 Based Regimen" (Press release). Replimune. 6 August 2026. Retrieved 7 August 2026.

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