AstraZeneca's Truqap Approved in US for Prostate Cancer
AstraZeneca announced that its drug Truqap (capivasertib), in combination with abiraterone and prednisone, has received US FDA approval. This marks the first and only targeted treatment for adult patients with PTEN-deficient metastatic androgen pathway modulation-na ve or sensitive prostate cancer. The approval is based on positive results from the CAPItello-281 Phase III trial, which demonstrated a statistically significant 19% reduction in the risk of radiographic disease progression or death, and a clinically meaningful improvement in median rPFS of 7.5 months. This approval addresses an aggressive form of prostate cancer associated with poor prognosis, affecting approximately one in four patients with mAPMN/S prostate cancer.
Key Highlights
- AstraZeneca's Truqap combination approved in US for PTEN-deficient metastatic androgen pathway modulation-na ve or sensitive prostate cancer.
- It is the first and only targeted treatment for this aggressive form of prostate cancer.
- Approval based on CAPItello-281 Phase III trial results, showing a 19% reduction in disease progression or death risk.
- Median radiographic progression-free survival (rPFS) improved by 7.5 months (33.2 months vs 25.7 months).
- The US FDA also approved a companion diagnostic test to detect PTEN deficiency.
- A regulatory application for the Truqap combination is currently under review in the EU.
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