Regulatory approval
Published by the Health Canada.
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 is written in the approval document as:
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.
Citation
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
| Type | Biomarker(s) | Cancer type | Therapy(ies) |
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