Therapeutic Response

ER positive, HER2-negative, PIK3CA somatic variants, and PR positive status confers therapeutic sensitivity to Fulvestrant in combination with Inavolisib and Palbociclib in patients with Invasive Breast Carcinoma.

Statements

Source and description
Itovebi (inavolisib) [package insert]. FDA. The U.S. Food and Drug Administration (FDA) granted approval to inavolisib in combination with palbociclib and fulvestrant for the treatment of adult patients with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy.
Itovebi (inavolisib) [product information]. EMA. The European Medicines Agency (EMA) has authorized inavolisib in combination with palbocicliab and fulvestrant for the treatment of adult patients with PIK3CA-mutated, estrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment. Patients previously treated with a CDK 4/6 inhibitor in the (neo)adjuvant setting should have had an interval of at least 12 months between termination of CDK 4/6 inhibitor treatment and the detection of recurrence. In pre/perimenopausal women and in men, endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.