AstraZeneca has announced that the European Commission has granted marketing authorisation for Truqap (capivasertib) in combination with fulvestrant for the treatment of adult patients with locally advanced or metastatic HR-positive, HER2-negative breast cancer with one or more PIK3CA, AKT1, or PTEN alterations, following recurrence or progression on or after endocrine-based therapy.

This approval is based on results from the CAPItello-291 Phase III trial, which demonstrated a statistically significant improvement in progression-free survival for patients receiving the combination therapy compared to fulvestrant alone.

The decision marks an important regulatory milestone for AstraZeneca and expands treatment options for eligible breast cancer patients across the European Union. For more information, visit AstraZeneca's official announcement.