FDA approves oncolytic virus
核心洞察
The FDA has approved Replimune's oncolytic immunotherapy Tudriqev (搜索) for unresectable advanced melanoma (搜索) that has progressed after PD-1 immunotherapy.
Tudriqev (搜索), formerly known as RP1, is engineered to selectively target and destroy cancer cells and is the second oncolytic virus approved.
Both approved oncolytic viruses are engineered live attenuated HSV-1 vectors encoding GM-CSF and a fusogenic GALV-GP-R (搜索) glycoprotein.
In August, the US Food and Drug Administration approved Replimune's oncolytic immunotherapy for patients with unresectable advanced melanoma (搜索) whose disease has progressed after PD-1 immunotherapy. The agent, Tudriqev (搜索) (vusolimogene oderparepvec), formerly known as RP1, is engineered to selectively target and destroy cancer cells.
Tudriqev (搜索) is the second oncolytic virus to reach approval. The first was Amgen's Imlygic (talimogene laherparepvec), also indicated for advanced skin cancer that cannot be removed by surgery.
Both oncolytic virus therapies are engineered versions of a live attenuated herpes simplex virus type 1 (搜索) (HSV-1) that encode the immune stimulatory protein GM-CSF together with a fusogenic GALV-GP-R (搜索) glycoprotein. GALV-GP-R, derived from gibbon ape leukemia virus, helps infected tumor cells fuse with uninfected tumor cells and thereby spread the virus.
Source: Nature Biotechnology