Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that PTEN-deficient status confers therapeutic sensitivity to Abiraterone acetate, Capivasertib, Prednisone in patients with Prostate Adenocarcinoma.

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 statement is based on a regulatory approval from the Food and Drug Administration:

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. AstraZeneca Pharmaceuticals, LP. Truqap (capivasertib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/218197s004lbl.pdf. Revised June 2026. Accessed October 6, 2026.

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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.