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 European Medicines Agency:
Itovebi, in combination with palbocicliab and fulvestrant, is indicated for the treatment of adult patients with PIK3CA-mutated, oestrogen 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.