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/2026/218197s006lbl.pdf. Revised September 2026. Accessed October 9, 2026.

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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-authorized 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. 21
TRUQAP is a kinase inhibitor indicated, in combination with abiraterone and prednisone, for the treatment of adult patients with metastatic androgen pathway modulation-naive or -sensitive (mAPMN/S) prostate cancer that is PTEN-deficient as detected by an FDA-authorized test. 1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations
Biomarkers
Cancer types
Therapies
Organizations Biomarkers Cancer types Therapies
FDA (1) ER positive, HER2-negative, PIK3CA oncogenic variants Invasive Breast Carcinoma Capivasertib, Fulvestrant
FDA (1) HER2-negative, PIK3CA oncogenic variants, PR positive Invasive Breast Carcinoma Capivasertib, Fulvestrant
FDA (1) ER positive, HER2-negative, PIK3CA oncogenic variants, PR positive Invasive Breast Carcinoma Capivasertib, Fulvestrant
FDA (1) AKT1 oncogenic variants, ER positive, HER2-negative Invasive Breast Carcinoma Capivasertib, Fulvestrant
FDA (1) AKT1 oncogenic variants, HER2-negative, PR positive Invasive Breast Carcinoma Capivasertib, Fulvestrant
FDA (1) AKT1 oncogenic 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
FDA (1) PTEN-deficient Prostate Adenocarcinoma Abiraterone acetate, Capivasertib, Prednisone