Melanoma Drug T-VEC Receives Recommendation for FDA Approval

An advisory panel to the U.S. Food and Drug Administration (FDA) has recommended approval of the investigational drug T-VEC (talimogene laherparepvec) for the treatment of metastatic melanoma. Biopharmaceutical company Amgen recently announced plans to move forward with approval process.[1]

The recommendation for approval is based on findings from a Phase III clinical trial in which T-VEC produced durable responses in people with advanced melanoma. These results were presented at the 2013 Annual Meeting of the American Society of Clinical Oncology (ASCO).[2]

T-VEC is a type of immunotherapy that uses a specially designed virus to destroy cancer cells. It is injected directly into the tumor. After acting locally within the tumor, it is intended to prompt an immune response against cancer cells elsewhere in the body.

To evaluate T-VEC for the treatment of advanced melanoma, researchers conducted a Phase III clinical trial that enrolled more than 400 patients. The patients had Stage IIIB, IIIC, or IV melanoma that could not be surgically removed. Patients were treated with either T-VEC or GM-CSF for up to 18 months.

The primary outcome of interest was a durable response (a partial or complete elimination of cancer that lasted for at least six months).

  • Durable responses occurred in 16% of patients in the T-VEC group and 2% of patients in the GM-CSF group. In the T-VEC group, durable responses were most common among patients with Stage III melanoma.
  • The overall response rate was 26% among patients in the T-VEC group and 6% among patients in the GM-CSF group.
  • The most common side effects of T-VEC were fatigue, chills, and fever.

These results demonstrated that T-VEC is active against advanced melanoma, and, according to the advisory panel, justify FDA approval of T-VEC.

Melanoma is dangerous because it is more likely than other types of skin cancer to spread (metastasize) to other parts of the body. Researchers continue to seek new and more effective drugs for the treatment of melanoma.


[1] Amgen to Discuss Details of the Biologics License Application for Talimogene Laherparepvec For Patients With Metastatic Melanoma [news release]. Amgen website. Available at: Accessed April 30, 2015.

[2] Andtbacka RHI, Collichio FA, Amatruda T et al. OPTiM: A randomized phase III trial of talimogene laherparepvec (T-VEC) versus subcutaneous (SC) granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment (tx) of unresected stage IIIB/C and IV melanoma. Presented at the 49th Annual Meeting of the American Society of Clinical Oncology. May 31-June 4, 2013; Chicago, IL. Abstract LBA9008.

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