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Nov 6, 2026Regulatory decision

FDA approves capivasertib combo for PTEN-deficient prostate cancer

The agency cleared capivasertib with abiraterone and prednisone for PTEN-deficient, androgen pathway modulation-naïve or -sensitive metastatic prostate cancer.

On June 12, 2026, the FDA approved capivasertib (Truqap, AstraZeneca) in combination with abiraterone and prednisone for adults with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer that is PTEN-deficient.1

The agency noted that this patient population was previously referred to using a different term, metastatic hormone-sensitive prostate cancer, before the current naming convention of androgen pathway modulation-naïve or -sensitive was adopted, according to the approval record. The indication applies specifically to patients whose disease is PTEN-deficient and who fall into the androgen pathway modulation-naïve or -sensitive category.1

The FDA did not include additional efficacy or safety data in the portion of the approval notice provided. Readers seeking trial results, dosing specifics, or biomarker testing requirements should consult the full FDA prescribing information and approval summary for further detail.

Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.