Health Products Regulatory Authority

National register of authorized medicines in the Republic of Ireland.

Documents

Documents published by the Health Products Regulatory Authority, containing at least one indication involving a biomarker.

Name	Indications	Statements
Arimidex (anastrozole) [summary of product characteristics]. HPRA.	3	9
Aromasin (exemestane) [summary of product characteristics]. HPRA.	1	1
Femara (letrozole) [summary of product characteristics]. HPRA.	4	12

Regulatory approvals

Approved indications from the Health Products Regulatory Authority for cancer drugs containing at least one biomarker.

Document	Indication	Statements
Arimidex (anastrozole) [summary of product characteristics]. HPRA.	Treatment of hormone receptor-positive advanced breast cancer in postmenopausal women.	3
Arimidex (anastrozole) [summary of product characteristics]. HPRA.	Adjuvant treatment of hormone receptor-positive early invasive breast cancer in postmenopausal women.	3
Arimidex (anastrozole) [summary of product characteristics]. HPRA.	Adjuvant treatment of hormone receptor-positive early invasive breast cancer in postmenopausal women who have received 2 to 3 years of adjuvant tamoxifen.	3
Aromasin (exemestane) [summary of product characteristics]. HPRA.	Aromasin is indicated for the adjuvant treatment of postmenopausal women with oestrogen receptor positive invasive early breast cancer (EBC), following 2 – 3 years of initial adjuvant tamoxifen therapy.	1
Femara (letrozole) [summary of product characteristics]. HPRA.	Adjuvant treatment of postmenopausal women with hormone receptor positive invasive early breast cancer.	3
Femara (letrozole) [summary of product characteristics]. HPRA.	Extended adjuvant treatment of hormone-dependent-invasive breast cancer in postmenopausal women who have received prior standard adjuvant tamoxifen therapy for 5 years.	3
Femara (letrozole) [summary of product characteristics]. HPRA.	First-line treatment in postmenopausal women with hormone-dependent advanced breast cancer.	3
Femara (letrozole) [summary of product characteristics]. HPRA.	Neo-adjuvant treatment of postmenopausal women with hormone receptor positive, HER-2 negative breast cancer where chemotherapy is not suitable and immediate surgery not indicated.	3

Therapeutic response

Precision oncology relationships for therapeutic response derived from Health Products Regulatory Authority's regulatory approvals.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	ER positive	Invasive Breast Carcinoma	Anastrozole
Sensitivity (+)	PR positive	Invasive Breast Carcinoma	Anastrozole
Sensitivity (+)	ER positive, PR positive	Invasive Breast Carcinoma	Anastrozole
Sensitivity (+)	ER positive	Invasive Breast Carcinoma	Anastrozole
Sensitivity (+)	PR positive	Invasive Breast Carcinoma	Anastrozole
Sensitivity (+)	ER positive, PR positive	Invasive Breast Carcinoma	Anastrozole
Sensitivity (+)	ER positive	Invasive Breast Carcinoma	Anastrozole
Sensitivity (+)	PR positive	Invasive Breast Carcinoma	Anastrozole
Sensitivity (+)	ER positive, PR positive	Invasive Breast Carcinoma	Anastrozole
Sensitivity (+)	ER positive	Invasive Breast Carcinoma	Exemestane
Sensitivity (+)	ER positive, PR positive	Invasive Breast Carcinoma	Letrozole
Sensitivity (+)	ER positive	Invasive Breast Carcinoma	Letrozole
Sensitivity (+)	PR positive	Invasive Breast Carcinoma	Letrozole
Sensitivity (+)	ER positive, PR positive	Invasive Breast Carcinoma	Letrozole
Sensitivity (+)	ER positive	Invasive Breast Carcinoma	Letrozole
Sensitivity (+)	PR positive	Invasive Breast Carcinoma	Letrozole
Sensitivity (+)	ER positive, PR positive	Invasive Breast Carcinoma	Letrozole
Sensitivity (+)	ER positive	Invasive Breast Carcinoma	Letrozole
Sensitivity (+)	PR positive	Invasive Breast Carcinoma	Letrozole
Sensitivity (+)	ER positive, HER2-negative	Invasive Breast Carcinoma	Letrozole
Sensitivity (+)	HER2-negative, PR positive	Invasive Breast Carcinoma	Letrozole
Sensitivity (+)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Letrozole