Regulatory approval

Published by the Food and Drug Administration.

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-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. 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-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.

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.

Therapeutic response

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

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