Piqray (alpelisib) [product monograph]. HC.
Regulatory approval published by the Health Canada.
Citation
Novartis Pharmaceuticals Canada Inc. Piqray (alpelisib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00082186.PDF. Revised October 2025. Accessed April 2026.
Regulatory approvals
Approved indications from this document for cancer drugs containing at least one biomarker.
| Indication |
Statements |
| 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. |
3 |
| 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. |
0 |
Therapeutic response
Precision oncology relationships for therapeutic response derived from this document.
| Organizations |
Biomarkers |
Cancer types |
Therapies |
|
|
HC (1)
|
ER positive, HER2-negative, PIK3CA Somatic variants
|
Invasive Breast Carcinoma |
Alpelisib,
Fulvestrant
|
|
|
HC (1)
|
HER2-negative, PIK3CA Somatic variants, PR positive
|
Invasive Breast Carcinoma |
Alpelisib,
Fulvestrant
|
|
|
HC (1)
|
ER positive, HER2-negative, PIK3CA Somatic variants, PR positive
|
Invasive Breast Carcinoma |
Alpelisib,
Fulvestrant
|
|