The FDA Gives Accelerated Approval to Melanoma Treatment

The FDA announced on August 6, 2026 that it has approved Replimune’s Tudriqev (vusolimogene oderparepvec-wtpg) for the treatment of unresectable advanced cutaneous melanoma in adults who experience disease progression with a programmed death receptor-1 (PD-1)-blocking antibody-based regimen.¹ Tudriqev, which is approved for use in combination with nivolumab, is a genetically modified oncolytic viral therapy. The treatment was approved through the agency’s accelerated approval pathway and was granted Breakthrough Therapy and Priority Review designations.

“This is a transformative moment for Replimune, marking years of pioneering research to bring TUDRIQEV to patients desperately in need of new treatment options for advanced melanoma,” said Sushil Patel, PhD, CEO of Replimune, in a press release.² “We are deeply grateful to the melanoma community, including patients and investigators who participated in the clinical trial, for their tremendous support of this approval. We also would like to thank the FDA for recognizing the urgency to get this therapy to patients. Replimune is now focused on critical activities to deliver TUDRIQEV to as many patients as possible.”

According to the FDA, “Anti-PD-1 refractory melanoma is advanced skin cancer that no longer responds to a widely used class of immunotherapy drugs. Despite treatment, the cancer may continue to grow because of developed mechanisms to evade the immune system’s ability to detect and destroy it.”¹

How Does Tudriqev Work?

The therapy is based on a modified herpes simplex virus type 1 (HSV-1) engineered to target and destroy cancer cells. The virus replicates itself inside a tumor and breaks the cancer cells apart, while also stimulating the body’s immune system to attack the cancer. It is injected directly into tumors once every 2 weeks for 8 consecutive doses. Dosage is determined by the size of the tumor. Used in combination with nivolumab, which is an anti-PD-1 immunotherapy, the FDA believes Tudriqev may create an anti-tumor immune response in patients. Nivolumab is given intravenously to patients beginning at the third week of treatment.

“For patients with advanced melanoma that has stopped responding to PD-1 blocking therapy, the prognosis is often devastating, and options have been far too limited. Clinicians managing these patients know this urgency firsthand,” said Karim Mikhail, B. Pharm., M.S., acting director of the FDA’s Center for Biologics Evaluation and Research, in a press release.¹ “Today’s important milestone gives oncologists a meaningful new tool—and more patients a fighting chance.”

“Advanced melanoma patients have few options after anti-PD-1 therapy and face high morbidity and poor survival outcomes,” said Michael K. Wong, MD, PhD, primary investigator of the IGNYTE study and Former Physician in Chief and Professor of Oncology at Roswell Park Comprehensive Cancer Center in Buffalo, NY, in a press release.² “With the approval of Tudriqev, we have a potent oncolytic immunotherapy that can be used in a broad population, including BRAF-naïve or pretreated, and adjuvant relapsed patients. Importantly, the therapy in combination with nivolumab drives immune activation with a favorable risk-benefit profile and can be injected into superficial and visceral lesions.”

Approval Details

The drug’s approval was based on data from an open-label, multiregional, single arm clinical trial that showed 1 in 4 patients responded to treatment. This positive response lasted a medium of nearly 14 months. The trial consisted of 140 adults with Stage IIIB, IIIC, or IV unresectable advanced melanoma whose disease had progressed for at least 8 consecutive weeks of being treated with an anti-PD-1-based therapy.

The agency also considered input from clinical experts and patient advocates in its approval decision. A meeting to discuss the application was held on July 30, 2026, and included patients, patient advocates, clinicians, and independent experts.

Adverse reactions reported with use of Tudriqev were mild and included fatigue, fever (pyrexia), infections, chills, musculoskeletal pain, nausea, diarrhea, injection site reaction, headache, cough, influenza-like illness, rash, vomiting, itching (pruritus), arthralgia, constipation, decreased appetite, dizziness, dyspnea, hemorrhage, edema, and abdominal pain. There is a risk of spreading a herpes infection to others or a herpes infection developing in patients.

“The approval of RP1 in combination with nivolumab is a meaningful step forward for patients with advanced melanoma who have failed to benefit from immunotherapy,” said Sam Guild, President of AIM at Melanoma, in a press release.² “Every year, more than 8500 people die of melanoma in the US, and new treatment options are urgently needed.”

Pharma Manufacturing Impacts

Some of the challenges associated with the manufacture of this type of product is the live-virus good manufacturing practice burden. Because this is a genetically engineered, replication-competent HSV-1, production may require dedicated biocontainment infrastructure, such as BSL-2 viral vector suites, segregated air handling, and strict facility controls to prevent cross-contamination with other biologics on site. The treatment also comes with cold-chain and site-of-care logistics due to the fact that it is injected intratumorally in a clinical setting, which requires cold-chain distribution and just-in-time delivery coordination with infusion/injection centers.^3,4

References

1. FDA approves new engineered viral immunotherapy for patients with treatment-resistant advanced melanoma. Press release. FDA. August 6, 2026. Accessed August 7, 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-new-engineered-viral-immunotherapy-patients-treatment-resistant-advanced-melanoma
2. 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. Relimune. August 6, 2026. Accessed August 7, 2026. https://ir.replimune.com/news-releases/news-release-details/replimune-announces-fda-accelerated-approval-tudriqevtm
3. Robilotti E, Zeitouni NC, Orloff M. Biosafety and biohazard considerations of HSV-1-based oncolytic viral immunotherapy. Front Mol Biosci. 2023 Sep 12 doi: 10.3389/fmolb.2023.1178382 https://pmc.ncbi.nlm.nih.gov/articles/PMC10546393/
4. Beyer S, Lipinski K. Specialized know-how and capacity to support demand for oncolytic viruses. Pharma’s Almanac. March 19, 2020. https://www.pharmasalmanac.com/articles/specialized-know-how-and-capacity-to-support-demand-for-oncolytic-viruses