The US Food and Drug Administration (FDA) has approved Amgen's biologics licence application (BLA) for Imlygic (talimogene laherparepvec), a genetically modified oncolytic virus therapy to treat melanoma lesions in the skin and lymph nodes.
Imlygic is indicated for the local treatment of unresectable cutaneous, subcutaneous and nodal lesions in patients with melanoma recurrent after initial surgery.
The therapy was approved based on therapeutic benefit showed in a pivotal study 005/05, and has not been shown to improve overall survival or have an effect on visceral metastases.
The company said that Imlygic is a genetically modified herpes simplex virus type 1 designed to replicate within tumours and produce an immunostimulatory protein called granulocyte-macrophage colony-stimulating factor (GM-CSF).
The multicentre, open-label, randomised Phase III OPTiM trial compared Imlygic to GM-CSF in patients with advanced melanoma (Stage IIIB, IIIC, or IV) that was not surgically resectable.
The trial's primary endpoint was durable response rate (DRR), defined as the percent of patients with complete response (CR) or partial response (PR) maintained continuously for a minimum of six months.
Amgen Research and Development executive vice-president Sean Harper said: "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.
"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 tumours."
Imlygic is injected directly into the melanoma lesions, where it replicates inside cancer cells and causes the cells to rupture and die.
A total of 436 patients were enrolled in the Phase III trial, in which 16.3% of patients treated with Imlygic achieved a durable response compared with 2.1% of patients treated with GM-CSF.
