Talimogene laherparepvec

USDailyMed:Talimogene laherparepvec Contraindicated L01XL02(WHO) AU:S4(Prescription only)US:℞-onlyEU:Rx-onlyIn general: ℞ (Prescription only) 1187560-31-1 DB13896 none 07730V90L6 D09966 Talimogene laherparepvec(T-VEC), sold under the brand nameImlygicamong others, is abiopharmaceuticalmedication used to treatmelanomathat cannot be operated on; it is injected directly into a subset of lesions which generates a systemic immune response against the recipient's cancer.The final four-year analysis from the pivotal phase 3 study upon which T-VEC was approved by the FDA showed a 31.5% response rate with a 16.9%complete response(CR) rate.‍‍‍‍‍‍​​​‍​​​​​​ There was also a substantial and statistically significant survival benefit in patients with earlier metastatic disease (stages IIIb-IVM1a) and in patients who had not received prior systemic treatment for melanoma. The earlier stage group had a reduction in the risk of death of approximately 50% with one in four patients appearing to have met, or be close to be reaching, the medical definition of cure.Real world use of talimogene laherparepvec have shown response rates of up to 88.5% with CR rates of up to 61.5%. 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 generallycellulitis. Talimogene laherparepvec is a genetically engineered herpes virus (anoncolytic herpes virus). Two genes were removed – one that shuts down an individual cell's defenses, and another that helps the virus evade the immune system – and a gene for humanGM-CSFwas added. The drug works by replicating in cancer cells, causing them to burst; it was also designed to stimulate an immune response against the patient's cancer, which has been demonstrated by multiple pieces of data, including regression of tumors which have not been injected with talimogene laherparepvec. The drug was created and initially developed by BioVex, Inc. and was continued byAmgen, which acquired BioVex in 2011.It was one of the firstoncolytic immunotherapyapproved globally; it was approved in the US in October 2015 and approved in Europe in December 2015.