Truqap (capivasertib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

Citation

AstraZeneca Pharmaceuticals, LP. Truqap (capivasertib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/218197s000lbl.pdf. Revised November 2023. Accessed October 30, 2024.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication

Statements

TRUQAP is a kinase inhibitor indicated, in combination with fulvestrant for the treatment of 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 or recurrence on or within 12 months of completing adjuvant therapy.

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Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
FDA (1)	ER positive, HER2-negative, PIK3CA somatic variants	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
FDA (1)	HER2-negative, PIK3CA somatic variants, PR positive	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
FDA (1)	ER positive, HER2-negative, PIK3CA somatic variants, PR positive	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
FDA (1)	AKT1 somatic variants, ER positive, HER2-negative	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
FDA (1)	AKT1 somatic variants, HER2-negative, PR positive	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
FDA (1)	AKT1 somatic variants, ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
FDA (1)	AKT1 amplification, ER positive, HER2-negative	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
FDA (1)	AKT1 amplification, HER2-negative, PR positive	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
FDA (1)	AKT1 amplification, ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
FDA (1)	ER positive, HER2-negative, PTEN nonsense variants	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
FDA (1)	HER2-negative, PR positive, PTEN nonsense variants	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
FDA (1)	ER positive, HER2-negative, PR positive, PTEN nonsense variants	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
FDA (1)	ER positive, HER2-negative, PTEN frameshift variants	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
FDA (1)	HER2-negative, PR positive, PTEN frameshift variants	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
FDA (1)	ER positive, HER2-negative, PR positive, PTEN frameshift variants	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
FDA (1)	ER positive, HER2-negative, PTEN splice site variants	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
FDA (1)	HER2-negative, PR positive, PTEN splice site variants	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
FDA (1)	ER positive, HER2-negative, PR positive, PTEN splice site variants	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
FDA (1)	ER positive, HER2-negative, PTEN deletion	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
FDA (1)	HER2-negative, PR positive, PTEN deletion	Invasive Breast Carcinoma	Capivasertib, Fulvestrant
FDA (1)	ER positive, HER2-negative, PR positive, PTEN deletion	Invasive Breast Carcinoma	Capivasertib, Fulvestrant