Difference between revisions of "Alpelisib (Piqray)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | *2019-05-24: Approved in combination with fulvestrant for postmenopausal women, and men, with [[Biomarkers#HR|hormone receptor (HR)]]-[[Biomarkers#Expression|positive]], [[Biomarkers#HER2|human epidermal growth factor receptor 2 (HER2)]]-[[Biomarkers#Normal_expression|negative]], [[Biomarkers#PIK3CA|PIK3CA]]-[[Biomarkers#SNV|mutated]], [[Contexts#Advanced_or_metastatic|advanced or metastatic]] [[breast cancer]] as detected by an FDA-approved test [[Contexts#Subsequent-line_therapy|following progression]] on or after an [[Regimen_classes#Endocrine-based_regimen|endocrine-based regimen]]. ''(Based on [https://clinicaltrials.gov/ct2/show/NCT02437318 SOLAR-1])'' |
==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
| − | * | + | *2020-07-27: Initial authorization |
| + | ==History of changes in Health Canada indication== | ||
| + | *2020-03-11: Initial notice of compliance in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor‑positive, HER2‑negative, PIK3CA‑mutated advanced or metastatic [[breast cancer]] after disease progression following an endocrine‑based regimen. | ||
==Also known as== | ==Also known as== | ||
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[[Category:FDA approved in 2019]] | [[Category:FDA approved in 2019]] | ||
[[Category:EMA approved in 2020]] | [[Category:EMA approved in 2020]] | ||
| + | [[Category:Health Canada approved in 2020]] | ||
Revision as of 00:27, 2 April 2023
Mechanism of action
From NCI Drug Dictionary: An orally bioavailable phosphatidylinositol 3-kinase (PI3K) inhibitor with potential antineoplastic activity. Alpelisib specifically inhibits PIK3 in the PI3K/AKT kinase (or protein kinase B) signaling pathway, thereby inhibiting the activation of the PI3K signaling pathway. This may result in inhibition of tumor cell growth and survival in susceptible tumor cell populations.
Diseases for which it is used
Patient drug information
History of changes in FDA indication
- 2019-05-24: Approved in combination with fulvestrant for postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen. (Based on SOLAR-1)
History of changes in EMA indication
- 2020-07-27: Initial authorization
History of changes in Health Canada indication
- 2020-03-11: Initial notice of compliance in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor‑positive, HER2‑negative, PIK3CA‑mutated advanced or metastatic breast cancer after disease progression following an endocrine‑based regimen.
Also known as
- Code name: BYL719
- Brand name: Piqray