11/25/2015
On October 27, the U.S. Food and Drug Administration (FDA) approved the first oncolytic virus therapy, talimogene laherparepvec (T-VEC, or Imlygic®).The agency approved T-VEC for the treatment of some patients with metastatic melanoma that cannot be surgically removed.
The approval was based on the results of a multicenter phase III clinical trial of patients with metastatic melanoma lesions in the skin and lymph nodes.
The approval was based on the results of a multicenter phase III clinical trial of patients with metastatic melanoma lesions in the skin and lymph nodes.
FDA Approves Talimogene Laherparepvec to Treat Metastatic Melanoma
November 25, 2015 by NCI Staff
On October 27, the U.S. Food and Drug Administration (FDA) approved the first oncolytic virus therapy, talimogene laherparepvec (T-VEC, or Imlygic®).The agency approved T-VEC for the treatment of some patients with metastatic melanoma that cannot be surgically removed.
The approval was based on the results of a multicenter phase III clinical trial of patients with metastatic melanoma lesions in the skin and lymph nodes.
Substantially more patients in the trial treated with T-VEC had a decrease in the size of their skin and lymph node lesions that lasted at least 6 months compared with patients treated withgranulocyte macrophage colony-stimulating factor.
Read more about the trial results on which the FDA based its approval.
.png)
No hay comentarios:
Publicar un comentario