FDA Grants Approval to Therapy for Advanced, Refractory Melanoma

The therapy can be used to treat an advanced form of skin cancer that doesn't respond to a widely-used class of immunotherapy drugs.

Key Highlights

  • - Tudriqev is a genetically modified herpes simplex virus designed to target and destroy melanoma cells.
  • - Approved for adult patients with unresectable advanced melanoma who have progressed after PD-1 therapy.
  • - Used in combination with nivolumab, an immune checkpoint inhibitor, to enhance treatment efficacy.
  • - Clinical trial involved 140 patients, with a 24% objective response rate observed.
  • - Represents a new therapeutic option for patients with anti-PD-1 refractory melanoma.

The FDA has granted an accelerated approval to Tudriqev, which is a genetically modified oncolytic viral therapy for treatment of advanced, refractory melanoma.

Tudriqev is used in combination with nivolumab for treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death receptor-1(PD-1)-blocking antibody-based regimen. Anti-PD-1 refractory melanoma is advanced skin cancer that no longer responds to a widely used class of immunotherapy drugs. The cancer may continue to grow despite treatment. 

Tudriqev is an oncolytic viral therapy based on a modified herpes simplex virus type 1 (HSV-1), engineered to selectively target and destroy cancer cells. The virus gets inside a tumor and then replicates and breaks cancer cells apart.

The therapy's safety and effectiveness were evaluated in a trial that enrolled 140 patients with unresectable advanced melanoma who experienced disease progression on at least eight consecutive weeks of prior anti-PD-1 based therapy. 24% of patients achieved an objective response.

About the Author

Matt MacKenzie

Associate Editor

Matt is Associate Editor for Healthcare Purchasing News.

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