Regulatory approval

Published by the Food and Drug Administration. Approved

The U.S. Food and Drug Administration granted approval to capivasertib 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. The efficacy of capivasertib in combination with fulvestrant was evaluated in CAPItello-291 (NCT04305496), which described biomarker eligibility as PIK3CA/AKT1 activating mutations or PTEN loss of function alterations.

This is written in the approval document as:

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.

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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Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations
Biomarkers
Cancer types
Therapies
Organizations Biomarkers Cancer types Therapies
FDA (2) ER positive, HER2-negative, PIK3CA oncogenic variants Invasive Breast Carcinoma Capivasertib, Fulvestrant
FDA (2) HER2-negative, PIK3CA oncogenic variants, PR positive Invasive Breast Carcinoma Capivasertib, Fulvestrant
FDA (2) ER positive, HER2-negative, PIK3CA oncogenic variants, PR positive Invasive Breast Carcinoma Capivasertib, Fulvestrant
FDA (2) AKT1 oncogenic variants, ER positive, HER2-negative Invasive Breast Carcinoma Capivasertib, Fulvestrant
FDA (2) AKT1 oncogenic variants, HER2-negative, PR positive Invasive Breast Carcinoma Capivasertib, Fulvestrant
FDA (2) AKT1 oncogenic variants, ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Capivasertib, Fulvestrant
FDA (2) AKT1 amplification, ER positive, HER2-negative Invasive Breast Carcinoma Capivasertib, Fulvestrant
FDA (2) AKT1 amplification, HER2-negative, PR positive Invasive Breast Carcinoma Capivasertib, Fulvestrant
FDA (2) AKT1 amplification, ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Capivasertib, Fulvestrant
FDA (2) ER positive, HER2-negative, PTEN nonsense variants Invasive Breast Carcinoma Capivasertib, Fulvestrant
FDA (2) HER2-negative, PR positive, PTEN nonsense variants Invasive Breast Carcinoma Capivasertib, Fulvestrant
FDA (2) ER positive, HER2-negative, PR positive, PTEN nonsense variants Invasive Breast Carcinoma Capivasertib, Fulvestrant
FDA (2) ER positive, HER2-negative, PTEN frameshift variants Invasive Breast Carcinoma Capivasertib, Fulvestrant
FDA (2) HER2-negative, PR positive, PTEN frameshift variants Invasive Breast Carcinoma Capivasertib, Fulvestrant
FDA (2) ER positive, HER2-negative, PR positive, PTEN frameshift variants Invasive Breast Carcinoma Capivasertib, Fulvestrant
FDA (2) ER positive, HER2-negative, PTEN splice site variants Invasive Breast Carcinoma Capivasertib, Fulvestrant
FDA (2) HER2-negative, PR positive, PTEN splice site variants Invasive Breast Carcinoma Capivasertib, Fulvestrant
FDA (2) ER positive, HER2-negative, PR positive, PTEN splice site variants Invasive Breast Carcinoma Capivasertib, Fulvestrant
FDA (2) ER positive, HER2-negative, PTEN deletion Invasive Breast Carcinoma Capivasertib, Fulvestrant
FDA (2) HER2-negative, PR positive, PTEN deletion Invasive Breast Carcinoma Capivasertib, Fulvestrant
FDA (2) ER positive, HER2-negative, PR positive, PTEN deletion Invasive Breast Carcinoma Capivasertib, Fulvestrant

Contributions

Date Contributor Description
2024-10-30 Van Allen lab Initial access of FDA approvals
2023-11-16 Food and Drug Administration Indication received traditional approval.