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AstraZeneca PLC on Friday said a Truqap combination has been approved by the US Food & Drug Administration as a first and only targeted treatment for PTEN-deficient metastatic hormone-sensitive prostate cancer. The Cambridge, England-based pharmaceuticals firm said the approval was based on results of CAPItello-281 which prospectively defined PTEN-deficient disease and showed Truqap combination reduced risk of radiographic disease progression or death by a ‘statistically significant’ 19%. Concurrently with this approval, the FDA also approved a companion diagnostic test to detect PTEN deficiency in tumours of patients with prostate adenocarcinoma. A regulatory application for the Truqap combination in this setting is under review in the EU based on the CAPItello-281 Phase III trial. Dave Fredrickson, executive vice president, Oncology Haematology Business Unit, AstraZeneca, said: ‘CAPItello-281 showed that for the first time, we can target a key driver of this disease to bring meaningful benefit to the one in four patients with this form of prostate cancer who urgently need biomarker-directed therapies. Today’s approval makes clear the importance of testing for actionable biomarkers, including PTEN deficiency, in prostate cancer.’ Shares in AstraZeneca closed down 1.1% at 13,432.00 pence each in London on Friday. Copyright 2026 Alliance News Ltd. All Rights Reserved.
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