publication date: Oct. 30, 2015

Imlygic Approved as First U.S. Oncolytic Viral Cancer Therapy


FDA approved Imlygic (talimogene laherparepvec) as the first oncolytic viral therapy in the U.S.

Imlygic, developed by Amgen, is indicated for the local treatment of unresectable cutaneous, subcutaneous and nodal lesions in patients with melanoma recurrent after initial surgery. Imlygic has not been shown to improve overall survival or have an effect on visceral metastases.

Imlygic is a genetically modified herpes simplex virus type 1 designed to replicate within tumors and produce granulocyte-macrophage colony-stimulating factor, an immunostimulatory protein. Imlygic causes cell lysis rupturing tumors and releasing tumor-derived antigens, which along with GM-CSF, may promote an anti-tumor immune response. However, the exact mechanism of action is unknown according to Amgen.

“Imlygic is the first clinical and regulatory validation of an oncolytic virus as a therapy, which Amgen is proud to bring to patients with a serious form of skin cancer. Not all melanoma patients currently benefit from available therapies, and Imlygic represents an important new option that can provide meaningful durable responses for patients with this aggressive and complex disease,” said Sean Harper, executive vice president of research and development at Amgen.

“Immunotherapy is an exciting area for cancer research, and we are currently studying Imlygic in combination with other immunotherapies in advanced melanoma and other solid tumors.”

The approval of Imlygic is based on data from Study 005/05, or OPTiM. OPTiM was a phase III, multicenter, open-label, randomized clinical trial comparing Imlygic to GM-CSF in patients with advanced melanoma (Stage IIIB, IIIC, or IV) that was not surgically … Continue reading 41-40 Imlygic Approved as First U.S. Oncolytic Viral Cancer Therapy

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