FDA approved Truqap (capivasertib) with fulvestrant for adult patients with hormone receptor-positive, human epidermal growth factor receptor-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations, as detected by an FDA-approved test, following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.
Further positive results from the phase III SERENA-6 trial showed camizestrant plus a cyclin-dependent kinase 4/6 inhibitor—palbociclib, ribociclib or abemaciclib—maintained its progression-free survival benefit with longer follow-up and delivered a statistically significant and clinically meaningful improvement in second progression-free survival, demonstrating sustained benefit beyond initial treatment.
