FDA expands Truqap approval to PTEN-deficient metastatic hormone-sensitive prostate cancer
- nuaxia
- 7 août
- 2 min de lecture
The biomarker-selected regimen adds an AKT inhibitor to abiraterone and prednisone for adults with newly diagnosed metastatic disease whose tumours show PTEN deficiency.
The US Food and Drug Administration has approved Truqap (capivasertib) with abiraterone and prednisone for adults with PTEN-deficient metastatic androgen pathway modulation-naïve or -sensitive prostate cancer, previously referred to as metastatic hormone-sensitive prostate cancer.
The expanded indication provides a new targeted combination for a molecularly defined patient group, although treatment requires FDA-authorised PTEN testing and monitoring for toxicities including hyperglycaemia, diarrhoea and cutaneous reactions.
Field | Content |
Alert Type | Drug Approval |
Drug Name | Truqap (capivasertib) |
Indication | In combination with abiraterone and prednisone for adults with metastatic androgen pathway modulation-naïve or -sensitive prostate cancer that is PTEN-deficient, as detected by an FDA-authorised test. |
Therapy Area(s) | Oncology; Prostate cancer |
Geography | United States (FDA) |
What Happened | On 12 June 2026, the FDA expanded Truqap’s approval to include capivasertib with abiraterone and prednisone for adults with PTEN-deficient metastatic androgen pathway modulation-naïve or -sensitive prostate cancer. The agency also approved the VENTANA PTEN (SP218) RxDx Assay as a companion diagnostic for identifying eligible patients. Truqap was previously approved in combination with fulvestrant for a biomarker-defined population with advanced breast cancer. (U.S. Food and Drug Administration) |
Why It Matters | PTEN deficiency is used to identify patients whose disease may be appropriate for this AKT-targeted combination, introducing a biomarker-directed option earlier in the metastatic prostate cancer pathway. In CAPItello-281, the regimen improved radiographic progression-free survival compared with abiraterone and placebo, but overall survival data were immature at the time of the analysis and the additional toxicity burden requires active clinical management. (U.S. Food and Drug Administration) |
Supporting Context | CAPItello-281 enrolled 1,012 adults with newly diagnosed PTEN-deficient disease. Median radiographic progression-free survival was 33.2 months with capivasertib and abiraterone versus 25.7 months with placebo and abiraterone, corresponding to a hazard ratio of 0.81. (U.S. Food and Drug Administration) |
Key Takeaway | The approval adds a PTEN-selected targeted regimen for metastatic hormone-sensitive prostate cancer, with eligibility dependent on companion diagnostic testing. |
What to Watch | Mature overall survival findings from CAPItello-281 and how routinely PTEN testing is incorporated into treatment selection for newly diagnosed metastatic disease. |
Primary Source | |
Relevant Date | 12 June 2026 |
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