Difference between revisions of "Capivasertib (Truqap)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *2023-11-16: Approved with fulvestrant for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-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. ''(Based on CAPItello-291)'' | + | *2023-11-16: Approved with fulvestrant for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-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. ''(Based on CAPItello-291)'' |
| − | *2023-11-16: Approved with fulvestrant for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations, as detected by an FDA-approved test, following recurrence on or within 12 months of completing adjuvant therapy. ''(Based on CAPItello-291)'' | + | *2023-11-16: Approved with fulvestrant for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic [[breast cancer]] with one or more PIK3CA/AKT1/PTEN-alterations, as detected by an FDA-approved test, following recurrence on or within 12 months of completing adjuvant therapy. ''(Based on CAPItello-291)'' |
==Also known as== | ==Also known as== | ||
Revision as of 12:31, 6 January 2024
Mechanism of action
From the NCI Drug Dictionary: A novel pyrrolopyrimidine derivative, and an orally available inhibitor of the serine/threonine protein kinase AKT (protein kinase B) with potential antineoplastic activity. AKT inhibitor AZD5363 binds to and inhibits all AKT isoforms. Inhibition of AKT prevents the phosphorylation of AKT substrates that mediate cellular processes, such as cell division, apoptosis, and glucose and fatty acid metabolism.
Diseases for which it is used
- CAPItello-291: Turner NC, Oliveira M, Howell SJ, Dalenc F, Cortes J, Gomez Moreno HL, Hu X, Jhaveri K, Krivorotko P, Loibl S, Morales Murillo S, Okera M, Park YH, Sohn J, Toi M, Tokunaga E, Yousef S, Zhukova L, de Bruin EC, Grinsted L, Schiavon G, Foxley A, Rugo HS; CAPItello-291 Study Group. Capivasertib in Hormone Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2023 Jun 1;388(22):2058-2070. link to original article PubMed NCT04305496
History of changes in FDA indication
- 2023-11-16: Approved with fulvestrant for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-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. (Based on CAPItello-291)
- 2023-11-16: Approved with fulvestrant for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations, as detected by an FDA-approved test, following recurrence on or within 12 months of completing adjuvant therapy. (Based on CAPItello-291)
Also known as
- Code name: AZD-5363
- Brand name: Truqap