EMA’s CHMP Recommends Amgen’s Immuno-Oncology Drug
Amgen reports that Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending that the company’s Imlygic (talimogene laherparepvec) be granted approval for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease. Imlygic is an oncolytic immunotherapy. The drug, administered via intralesional injection, is designed to cause the death of tumor cells and to initiate an anti-tumor immune response.
Following this CHMP opinion, Amgen expects a decision on the marketing authorization from the European Commission in the coming months. Imlygic is also under review by the US Food and Drug Administration.
Imlygic is a genetically modified herpes simplex type 1 virus that is injected directly into tumors. IMLYGIC replicates inside tumor cells and produces GM-CSF, an immunostimulatory protein. Imlygic then causes the cell to rupture and die in a process called lysis. The rupture of the cancer cells causes the release of tumor-derived antigens, which together with virally derived GM-CSF may help to promote an anti-tumor immune response. However, the exact mechanism of action is unknown.