Regulatory approval

Published by the Food and Drug Administration. Approved

The U.S. Food and Drug Administration granted approval to capivasertib 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. The package insert notes that mAPMN/S prostate cancer was previously referred to as metastatic hormone-sensitive prostate cancer (mHSPC). This indication is supported by CAPItello-281 (NCT04493853), a randomized, double-blind, placebo-controlled, multicenter trial in which PTEN deficiency status was defined as >= 90% of viable malignant cells with no specific cytoplasmic staining, as determined by central testing with the immunohistochemistry-based VENTANA PTEN (SP218) RxDx Assay.

This is written in the approval document as:

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.

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.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	PTEN-deficient	Prostate Adenocarcinoma	Abiraterone acetate, Capivasertib, Prednisone

Contributions

Date	Contributor	Description
2026-10-09	Van Allen lab	Initial curation of FDA's approval of Truqap (capivasertib) for PTEN-deficient mAPMN/S prostate cancer.
2026-06-12	Food and Drug Administration	Indication received traditional approval.