Английская Википедия:Capivasertib
Шаблон:Short description Шаблон:Use American English Шаблон:Use dmy dates Шаблон:Cs1 config Шаблон:Infobox drug
Capivasertib, sold under the brand name Truqap, is an anti-cancer medication used for the treatment of breast cancer.[1][2] It is taken by mouth.[1]
The most common adverse reactions include diarrhea, cutaneous adverse reactions, increased random glucose, decreased lymphocytes, decreased hemoglobin, increased fasting glucose, nausea, fatigue, decreased leukocytes, increased triglycerides, decreased neutrophils, increased creatinine, vomiting, and stomatitis.[3]
In November 2023, capivasertib was approved in the United States for people with hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer when used in combination with fulvestrant.[3][4][5] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[6]
Medical uses
Capivasertib, used in combination with fulvestrant (Faslodex), is indicated for adults with hormone receptor-positive, human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations, as detected by an FDA-approved test, following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within twelve months of completing adjuvant therapy.[1][3]
Mechanism of Action
Capivasertib inhibits 3 isoforms of serine and threonine kinase AKT, specifically AKT1, AKT2, and AKT3, and inhibits downstream phosphorylation of AKT substrates. Activation of upstream signaling pathways is the result of AKT activations in tumors, as well as mutations in AKT1, loss of phosphatase and tensin homolog (PTEN) function. Mutations in the catalytic subunit alpha of phosphatidylinositol 3-kinase (PIK3CA) can also result in AKT activation. [7]
History
Efficacy was evaluated in CAPItello-291 (NCT04305496), a randomized, double-blind, placebo-controlled, multicenter trial in 708 participants with locally advanced or metastatic HR-positive, HER2-negative breast cancer, of which 289 participants had tumors with PIK3CA/AKT1/PTEN-alterations.[3] All participants were required to have progression on aromatase inhibitor-based treatment.[3] Participants could have received up to two prior lines of endocrine therapy and up to one line of chemotherapy for locally advanced or metastatic disease.[3]
Society and culture
Legal status
Capivasertib was approved for medical use in the United States in November 2023.[3] The FDA granted the application for capivasertib fast track designation.[6]
References
External links
Шаблон:Portal bar Шаблон:Authority control
- ↑ 1,0 1,1 1,2 Ошибка цитирования Неверный тег
<ref>; для сносокTruqap FDA labelне указан текст - ↑ Шаблон:Cite journal
- ↑ 3,0 3,1 3,2 3,3 3,4 3,5 3,6 Шаблон:Cite web Шаблон:PD-notice
- ↑ Шаблон:Cite web
- ↑ Шаблон:Cite press release
- ↑ 6,0 6,1 Шаблон:Cite report
- ↑ Шаблон:Cite web
