Hormone receptor

26 EU-approved indications of 18 drugs need a Hormone receptor result, in 2 tumour types, most of them in breast cancer and triple-negative breast cancer.

Approved indications26

Drug	Biomarker requirement	Regimen	Setting	Conditions

Triple-negative breast cancer1
Datopotamab deruxtecan Datroway	Triple-negative (ER-negative, PR-negative, HER2-negative)	Monotherapy	1L advanced	Not candidates for PD-1/PD-L1 inhibitor therapy

Breast cancer25
Abemaciclib Verzenios	HER2-negative	+ endocrine therapy	Adj. early	Node-positive; high risk of recurrence; In pre- or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist
Neratinib Nerlynx	HER2 IHC 3+ or IHC 2+/ISH-positive, HR-positive	Monotherapy	Adj. early	After adjuvant trastuzumab-based therapy completed less than one year ago
Ribociclib Kisqali	HER2-negative	+ an aromatase inhibitor	Adj. early	High risk of recurrence; in pre- or perimenopausal women, or in men, the aromatase inhibitor should be combined with a luteinising hormone-releasing hormone (LHRH) agonist
Abemaciclib Verzenios	HER2-negative	+ an aromatase inhibitor or fulvestrant	1L advanced	Women; In pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist
Camizestrant Etcamah	ESR1 mutation, ER-positive, HER2-negative	+ a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib)	1L advanced	During first-line endocrine therapy + CDK4/6 inhibitor, before progression; In pre- or peri-menopausal women and in men, should be combined with a LHRH agonist or antagonist
Fulvestrant Faslodex		Monotherapy	1L advanced	No prior endocrine therapy; Postmenopausal women
Ribociclib Kisqali	HER2-negative	+ an aromatase inhibitor or fulvestrant	1L advanced	Women; initial endocrine-based therapy; in pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist
Toremifene Fareston		Monotherapy	1L metastatic	Postmenopausal
Abemaciclib Verzenios	HER2-negative	+ an aromatase inhibitor or fulvestrant	2L advanced	After prior endocrine therapy; Women; In pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist
Alpelisib Piqray	PIK3CA mutation, HR-positive, HER2-negative	+ fulvestrant	2L advanced	Following an endocrine-based regimen; Postmenopausal women, and men
Capivasertib Truqap	One or more PIK3CA/AKT1/PTEN-alterations, ER-positive, HER2-negative	+ fulvestrant	2L advanced	Recurrence or progression on or after an endocrine-based regimen; In pre- or perimenopausal women, TRUQAP plus fulvestrant should be combined with a LHRH agonist; for men, administration of LHRH agonist according to current clinical practice standards should be considered
Datopotamab deruxtecan Datroway	HER2-negative	Monotherapy	2L advanced	After endocrine therapy and at least one line of chemotherapy in the advanced setting
Elacestrant Orserdu	ESR1 mutation, ER-positive, HER2-negative	Monotherapy	2L advanced	After at least one line of endocrine therapy including a CDK 4/6 inhibitor; Postmenopausal women, and men
Everolimus Afinitor	HER2-negative	+ exemestane	2L advanced	Recurrence or progression following a non-steroidal aromatase inhibitor; Postmenopausal women; without symptomatic visceral disease
Fulvestrant Faslodex	HER2-negative	+ palbociclib	2L advanced	After prior endocrine therapy; Women; In pre- or perimenopausal women, the combination treatment with palbociclib should be combined with a LHRH agonist
Fulvestrant Faslodex		Monotherapy	2L advanced	Disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy; Postmenopausal women
Imlunestrant Inluriyo	ESR1 mutation, ER-positive, HER2-negative	Monotherapy	2L advanced	After prior treatment with an endocrine based regimen; In pre- or perimenopausal women, or men, Inluriyo should be combined with a luteinising hormone-releasing hormone (LHRH) agonist
Inavolisib Itovebi	PIK3CA mutation, ER-positive, HER2-negative	+ palbociclib and fulvestrant	2L advanced	After adjuvant endocrine treatment with recurrence on or within 12 months of completion (if previously treated with a CDK 4/6 inhibitor in the (neo)adjuvant setting, an interval of at least 12 months between termination of CDK 4/6 inhibitor treatment and detection of recurrence is required); In pre/perimenopausal women and in men, endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist
Palbociclib Ibrance	HER2-negative	+ fulvestrant	2L advanced	After prior endocrine therapy; Women; in pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist
Ribociclib Kisqali	HER2-negative	+ an aromatase inhibitor or fulvestrant	2L advanced	After prior endocrine therapy; Women; in pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist
Trastuzumab deruxtecan Enhertuconditional	IHC 1+ or IHC 2+/ISH-negative or IHC 0 with membrane staining (faint, incomplete, ≤10% of tumour cells), HER2-low or HER2-ultralow, HR-positive	Monotherapy	2L advanced	After at least one endocrine therapy in the metastatic setting; Not considered suitable for endocrine therapy as the next line of treatment
Sacituzumab govitecan Trodelvy	HER2-negative	Monotherapy	3L+ advanced	After endocrine-based therapy, and at least two additional systemic therapies in the advanced setting
Lapatinib Tyverb	HER2 IHC 3+ or IHC 2+/ISH-positive, HR-positive	+ an aromatase inhibitor	Any line metastatic	Postmenopausal women; not currently intended for chemotherapy
Palbociclib Ibrance	HER2-negative	+ an aromatase inhibitor	Any line advanced	In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist
Trastuzumab Herceptin, Tuznue	HER2 IHC 3+ or IHC 2+/ISH-positive, HR-positive	+ aromatase inhibitor	Any line metastatic	No prior trastuzumab; Postmenopausal

Hormone receptor by tumour

Label wording26

The sentence from section 4.1 of the SmPC that each indication above comes from.

Trastuzumab (Herceptin, Tuznue)
in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab.
Trastuzumab deruxtecan (Enhertu)
• hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment (see sections 4.2 and 5.1).
Everolimus (Afinitor)
Afinitor is indicated for the treatment of hormone receptor-positive, HER2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.
Camizestrant (Etcamah)
Etcamah in combination with a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) is indicated for the treatment of adult patients with ER-positive, HER2-negative, locally advanced or metastatic breast cancer upon detection of ESR1-mutation and without disease progression during first-line endocrine therapy in combination with a CDK4/6 inhibitor (for biomarker based patient-selection, see section 4.2 and 5.1).
Datopotamab deruxtecan (Datroway)
Datroway as monotherapy is indicated for the first-line treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy (see section 5.1).
Datopotamab deruxtecan (Datroway)
Datroway as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting (see section 5.1).
Alpelisib (Piqray)
Piqray is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following an endocrine-based regimen (see section 5.1 and for biomarker-based patient selection see section 4.2).
Sacituzumab govitecan (Trodelvy)
Trodelvy as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting (see section 5.1).
Abemaciclib (Verzenios)
Verzenios in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive early breast cancer at high risk of recurrence (see section 5.1).
Abemaciclib (Verzenios)
Verzenios is indicated for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.
Abemaciclib (Verzenios)
Verzenios is indicated for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.
Ribociclib (Kisqali)
Kisqali in combination with an aromatase inhibitor is indicated for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer at high risk of recurrence (see section 5.1 for selection criteria).
Ribociclib (Kisqali)
Kisqali is indicated for the treatment of women with HR-positive, HER2-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.
Ribociclib (Kisqali)
Kisqali is indicated for the treatment of women with HR-positive, HER2-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.
Elacestrant (Orserdu)
ORSERDU monotherapy is indicated for the treatment of postmenopausal women, and men, with estrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation who have disease progression following at least one line of endocrine therapy including a CDK 4/6 inhibitor.
Palbociclib (Ibrance)
IBRANCE is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer: - in combination with an aromatase inhibitor;
Palbociclib (Ibrance)
IBRANCE is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer: - in combination with fulvestrant in women who have received prior endocrine therapy (see section 5.1).
Fulvestrant (Faslodex)
• as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women: - not previously treated with endocrine therapy, or
Fulvestrant (Faslodex)
• as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women: - not previously treated with endocrine therapy, or - with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy.
Fulvestrant (Faslodex)
• in combination with palbociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy (see section 5.1). In pre- or perimenopausal women, the combination treatment with palbociclib should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.
Inavolisib (Itovebi)
Itovebi, in combination with palbociclib 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 (see section 5.1).
Capivasertib (Truqap)
TRUQAP is indicated in combination with fulvestrant for the treatment of adult patients with oestrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following recurrence or progression on or after an endocrine-based regimen (see section 5.1).
Imlunestrant (Inluriyo)
Inluriyo is indicated as monotherapy for the treatment of adult patients with oestrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1-mutation, who have disease progression following prior treatment with an endocrine based regimen (for biomarker-based patient selection, see section 4.2).
Lapatinib (Tyverb)
in combination with an aromatase inhibitor for postmenopausal women with hormone receptor positive metastatic disease, not currently intended for chemotherapy.
Neratinib (Nerlynx)
Nerlynx is indicated for the extended adjuvant treatment of adult patients with early-stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago.
Toremifene (Fareston)
First line hormone treatment of hormone-dependent metastatic breast cancer in postmenopausal patients. Fareston is not recommended for patients with estrogen receptor negative tumours.