FDA approves Imlygic (talimogene laherparepvec) to treat unresectable cutaneous, subcutaneous and nodal lesions in patients with melanoma- Amgen

Amgen has announced that the FDA has approved the Biologics License Application for Imlygic (talimogene laherparepvec), a genetically modified oncolytic viral therapy 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 the first oncolytic viral therapy approved by the FDA based on therapeutic benefit demonstrated in a pivotal study. 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). Imlygic causes tumour cell lysis, releasing tumour-derived antigens, which along with GM-CSF, may promote an anti-tumour immune response. However, the exact mechanism of action is unknown.

Comment: The safety and efficacy of Imlygic were evaluated in a multicentre study of 436 participants with metastatic melanoma that could not be surgically removed. The participants’ melanoma lesions in the skin and lymph nodes were treated with Imlygic or a comparator therapy for at least six months, or until there were no remaining injectable lesions. The study showed that 16.3% of the study participants who received Imlygic experienced a decrease in size of their skin and lymph node lesions, lasting for a minimum of six months, compared to 2.1% of study participants receiving the comparator therapy.

Comment: Imlygic was CHMP recommended in October 2015.