Vusolimogene oderparepvec
| Clinical data | |
|---|---|
| Trade names | Tudriqev |
| Other names | RP1, vusolimogene oderparepvec-wtpg |
| AHFS/Drugs.com | tudriqev |
| License data | |
| Routes of administration | Intratumor injection |
| Drug class | Antineoplastic |
| ATC code |
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| 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 - a biopharmaceutical - 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 an accelerated approval for medical use in the United States in August 2026; the approval came with obligations for Replimmune to conduct further studies.[2][3]
Medical uses
[edit]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
[edit]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
[edit]Vusolimogene oderparepvec is a biopharmaceutical drug; it 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
[edit]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
[edit]Legal status
[edit]Vusolimogene oderparepvec was granted an accelerated approval for medical use in the United States in August 2026.[2]
The US Food and Drug Administration (FDA) granted the application for vusolimogene oderparepvec, in combination with nivolumab, breakthrough therapy designation to Replimune.[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]
Names
[edit]Vusolimogene oderparepvec is the international nonproprietary name.[6]
Vusolimogene oderparepvec is sold under the brand name Tudriqev.[2][7]
References
[edit]- 1 2 3 4 https://www.fda.gov/media/194127/download
- 1 2 3 4 5 6 7 8 9 10 11 "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.
This article incorporates text from this source, which is in the public domain. - ↑ <ref>"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. This article incorporates text from this source, which is in the public domain.
- ↑ "Tudriqev". U.S. Food and Drug Administration (FDA). 6 August 2026. Retrieved 7 August 2026. This article incorporates text from this source, which is in the public domain.
- ↑ Ma VT, Steimle AK, Patel JD, Burkey C, Moser JC, Javed A, et al. (1 July 2026). "Updates on intratumoral therapies in melanoma". Cancer. 132 (13) e70400. doi:10.1002/cncr.70400. PMC 13301002. PMID 42349466.
- ↑ World Health Organization (2022). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 87". WHO Drug Information. 36 (1). hdl:10665/352794.
- ↑ "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.
External links
[edit]- "Vusolimogene Oderparepvec ( Code - C158074 )". EVS Explore.
- Clinical trial number NCT03767348 for "Study of RP1 Monotherapy and RP1 in Combination With Nivolumab (IGNYTE) (IGNYTE)" at ClinicalTrials.gov
