AstraZeneca PLC Form 6-K Filing

This Form 6-K filing from AstraZeneca PLC announces the U.S. Food and Drug Administration (FDA) approval of Truqap (capivasertib) in combination with abiraterone and prednisone. This combination is the first and only targeted treatment for adult patients with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive prostate cancer. The approval, based on the CAPItello-281 Phase III trial, demonstrated a 19% reduction in the risk of radiographic disease progression or death. The trial also showed a median radiographic progression-free survival of 33.2 months for the Truqap combination versus 25.7 months for the comparator arm. The filing also notes the FDA approval of a companion diagnostic test to detect PTEN deficiency in prostate cancer tumors. A similar regulatory application is under review in the EU. The safety profile of Truqap in this combination was consistent with known profiles, with Grade 3 or higher adverse events occurring in 67% of patients.