Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that HER2-negative, PIK3CA somatic variants, PR positive status confers therapeutic sensitivity to Alpelisib, Fulvestrant in patients with Invasive Breast Carcinoma.
Health Canada approved alpelisib in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor-positive, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer after disease progression following an endocrine-based regimen.
This statement is based on a regulatory approval from the Health Canada:
PIQRAY (alpelisib), in combination with fulvestrant, is indicated for the treatment of postmenopausal women, and men, with hormone receptor-positive, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer after disease progression following an endocrine-based regimen.