Talimogene laherparepvec

Talimogene laherparepvec is delivered by injecting it directly into tumors, thereby creating a systemic anti-tumor immune response. Talimogene laherparepvec has been shown to extend survival in patients with Stage IIIb-IVM1a melanoma and patients who have not received prior systemic therapy for melanoma. ==Adverse effects==

Around half of people treated with talimogene laherparepvec in clinical trials experienced fatigue and chills; around 40% had fever, around 35% had nausea, and around 30% had flu-like symptoms as well as pain at the injection site. The reactions were mild to moderate in severity; 2% of people had severe reactions and these were generally cellulitis. ), dehydration, confusion, anxiety, depression, dizziness, insomnia, ear pain, fast heart beating, deep vein thrombosis, high blood pressure, flushing, shortness of breath when exercising, sore throat, symptoms of the common cold, stomach pain, back pain, groin pain, weight loss, or oozing from the injection site. ==Pharmacology==

Talimogene laherparepvec is taken up by normal cells and cancer cells like the wild type herpes simplex virus, it is cleared in the same way. ==Mechanism==

Talimogene laherparepvec directly destroys the cancer cells it infects, inducing a systemic immune response against the patient's cancer. While talimogene laherparepvec is using the cell's translation machinery to replicate, it also uses it to make the cell create GM-CSF. GM-CSF is secreted or released when the cancer cell bursts, attracting dendritic cells to the site, which pick up the tumor antigens, process them, and then present them on their surface to cytotoxic (killer) T cells which in turn sets off an immune response. ==Composition==

Talimogene laherparepvec is a biopharmaceutical drug; it is an oncolytic herpes virus that was created by genetically engineering a strain of herpes simplex virus 1 (HSV-1) taken from a person infected with the virus, rather than a laboratory strain. In wild herpes virus, ICP47 suppresses the immune response to the virus; it was removed because the drug was designed with the intention of activating the immune system. ==History==

The first oncolytic virus to be approved by a regulatory agency was a genetically modified adenovirus named H101 by Shanghai Sunway Biotech. It gained regulatory approval in 2005 from China's State Food and Drug Administration (SFDA) for the treatment of head and neck cancer. Talimogene laherparepvec is the world's first approved oncolytic immunotherapy, i.e. it was also designed to provide systemic anti-tumor effects through the induction of an anti-tumor immune response. Talimogene laherparepvec was created and initially developed by BioVex, Inc. under the brand OncoVEXGM-CSF. Development was continued by Amgen, which acquired BioVex in 2011. and moved its headquarters to Woburn, Massachusetts in 2005, leaving about half its employees in the UK. The phase II clinical trial in melanoma was published in 2009 and the phase III trial was published in 2013. Talimogene laherparepvec was approved by the US Food and Drug Administration to treat melanoma in October 2015. It was the first approval of an oncolytic virus and the first approval of a gene therapy in the West. == Society and culture ==

Economics Amgen estimated that talimogene laherparepvec would be priced at per patient at the time it was approved. • == References ==