Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that ER positive, HER2-negative, PIK3CA somatic variants status confers therapeutic sensitivity to Fulvestrant, Inavolisib, Palbociclib in patients with Invasive Breast Carcinoma.
This statement is based on a regulatory approval from the Health Canada:
ITOVEBI (inavolisib film-coated tablets), in combination with palbociclib and fulvestrant, is indicated 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, following recurrence on or after completing adjuvant endocrine treatment.