Tudriqev Approval: Essential Oncology Nursing Insights

The FDA granted accelerated approval to vusolimogene oderparepvec-wtpg (Tudriqev) in combination with nivolumab (Opdivo) for adults with unresectable advanced cutaneous melanoma progressing on anti-PD-1 therapy. This approval marks the arrival of a first-in-class oncolytic immunotherapy, bringing both hope to patients and a shift in clinical practice for oncology nurses.

According to Michael K. Wong, MD, PhD, FRCPC, the primary investigator of the pivotal IGNYTE study, this regimen requires collaborative operational adjustments. Efficacy findings from the trial showed an objective response rate of 24.2% and a median duration of response of 14.1 months in the 91 efficacy-evaluable patients.

Nursing teams are at the forefront of managing the localized dosing protocol. Wong, in an interview with Oncology Nursing News, noted the dosing calculation is highly straightforward. "It's actually a very simplified graph and it's basically one cc per centimeter," he explained.

Clinical teams measure each injectable lesion on treatment days to determine the volume, capped at a maximum of 10 mL per dose.

A unique challenge of melanoma is tumor heterogeneity. "Melanoma is one of those cancers where we know there's heterogeneity within metastases," Wong observed. Because "every deposit may differ a little bit from where it came from," he stated that "it behooves us to make sure we inject as many as we can."

Nursing workflows will vary based on tumor location. Superficial injections can be managed directly in the outpatient setting. "These injections can be done superficially. I've done them personally myself in clinic and I've trained my mid-level practitioners to do it," Wong noted. However, deep or visceral metastases in the liver, lung, or peritoneal cavity require distinct coordination.

Wong advised oncology teams to "pull in the help of your interventional radiologist" to perform these deep injections safely using image guidance.

Because this is a live, genetically modified herpes simplex virus type 1 (HSV-1) therapy, clinical teams and patients often voice biosafety concerns. Wong quickly demystified these anxieties: "With all the experience we have never had a single case of transmission." He emphasized that the virus has been modified so it "doesn't propagate like a natural herpes virus." For patient and caregiver education, nurses can reassure families that "you don't catch herpes from breathing it in or even touching people as long as you're wearing a Band-aid."

However, nurses must coordinate clinic schedules to segregate severely immunosuppressed patients.

Ultimately, successful implementation of this novel combination therapy relies on oncology nurses. By mastering these clinical administration steps, nursing teams will successfully deliver this next-generation therapy to patients.

References

1. US Food and Drug Administration. FDA grants accelerated approval to vusolimogene oderparepvec-wtpg in combination with nivolumab for melanoma. FDA website. Published August 6, 2026. Accessed August 10, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-vusolimogene-oderparepvec-wtpg-combination-nivolumab-melanoma
2. Wong MK, Milhem MM, Sacco JJ, et al. RP1 combined with nivolumab in advanced anti–PD-1–failed melanoma (IGNYTE). J Clin Oncol. 2025;43(33):3589-3599. doi:10.1200/JCO-25-01346
3. Replimune Group, Inc. 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. GlobeNewswire website. Published August 6, 2026. Accessed August 10, 2026. https://ir.replimune.com/node/11461/pdf