LONDON (dpa-AFX) - AstraZeneca's (AZN,AZN.L,ZEG.DE,AZN.ST) Truqap (capivasertib), in combination with abiraterone and prednisone, has been approved in the US as the first and only targeted treatment for adult patients with PTEN-deficient metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer-previously referred to as metastatic hormone-sensitive prostate cancer (mHSPC)-as detected by a US Food and Drug Administration (FDA)-authorised test.
Concurrently with this approval, the US Food and Drug Administration also authorised a companion diagnostic test designed to detect PTEN deficiency in tumours of patients with prostate adenocarcinoma. This ensures that eligible individuals can be accurately identified for treatment with the Truqap combination.
A regulatory application for the Truqap regimen in this setting is currently under review in the European Union. The submission is supported by data from the CAPItello-281 Phase III trial, which evaluated the efficacy and safety of the combination in patients with PTEN-deficient metastatic prostate cancer.
AZN closed Friday's regular trading at $178.75 down $3.53 or 1.94%. But in the after-hours trading the stock gained $2.05 or 1.15%.
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