FDA approved Itovebi (inavolisib) with palbociclib (Ibrance) and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, human epidermal growth-factor receptor 2-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine 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.
