The drug works by replicating in cancer cells, causing them to burst; it was also designed to stimulate an immune response against the patients 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 by Amgen, which acquired BioVex in 2011. It was one of the first oncolytic immunotherapy approved globally; it was approved in the US in October 2015 and approved in Europe in December 2015. Medical uses
Talimogene laherparepvec is delivered by injecting it directly into tumors, thereby creating a systemic anti-tumor immune response.In the US, talimogene laherparepvec is FDA approved to treat Stage IIIb-IVM1c melanoma patients for whom surgical intervention is not appropriate and with tumors which can be directly injected; the EMA approved population in Europe is for Stage IIIb-IVM1a.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.More than 10% of people had edema, headache, cough, vomiting, diarrhea, constipation, muscle pain, or joint pain.
Gestation is the period of development during the carrying of an embryo, and later fetus, inside viviparous animals (the embryo develops within the parent). It is typical for mammals, but also occurs for some non-mammals. Mammals during pregnancy can have one or more gestations at the same time, for example in a multiple birth.The time interval of a gestation is called the gestation period. In obstetrics, gestational age refers to the time since the onset of the last menses, which on average is fertilization age plus two weeks. Mammals
In mammals, pregnancy begins when a zygote (fertilized ovum) implants in the females uterus and ends once the fetus leaves the uterus during labor or an abortion (whether induced or spontaneous). Humans
In humans, pregnancy can be defined clinically or biochemically. Clinically, pregnancy starts from the mothers last missed period. Biochemically, pregnancy starts when a womans human chorionic gonadotropin (hCG) levels rise above 25 mIU/mL.Human pregnancy can be divided into three trimesters, each approximately three months long: the first, second, and third trimester. The first trimester is from the last menstrual period through the 13th week, the second trimester is 14th–28/29th week, and the third trimester is 29/30th–42nd week. Birth normally occurs at a gestational age of about 40 weeks, though it is common for births to occur from 37 to 42 weeks.