FDA approves capivasertib with abiraterone and prednisone for PTEN deficient androgen pathway modulation-naïve or -sensitive prostate cancer

FDA

12 June 2026 - Today, the FDA approved capivasertib (Truqap, AstraZeneca) in combination with abiraterone and prednisone for adults with metastatic androgen pathway modulation naïve or sensitive prostate cancer (previously referred to as metastatic hormone-sensitive prostate cancer) that is PTEN deficient as detected by an FDA authorized test.

The FDA also approved the VENTANA PTEN (SP218) RxDx Assay (Ventana Medical Systems/Roche Diagnostics) as a companion diagnostic device to identify patients with PTEN deficient prostate cancer for treatment with capivasertib.

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Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Registration