Talimogene Laherparepvec submitted for MAA to European Medical Agency

Talimogene Laherparepvec , an investigational agent has been submitted for MAA( Marketing Authorisation Application) to  the European Medical Agency for the treatment of  adults with metastatic Melanoma . The drug is an intra-tumoral  injection that is designed to initiate anti tumor immune response.
       The randomized, global and open label phase 3 clinical trial evaluating safety and efficacy of Talimogene Laherparepvec data of patients with 3b or 3c melanoma in more than 400 patients.
             Mechanism of action of Talimogene Laherparepvrec :
When it is directly injected in to tumor's it replicates inside the tumor cell causing the cell to rupture and die (Lysis)
         This ruptured cancer cell can release tumor derived antigen's , along with GM-CSF which can stimulate system wide immune response.