Estrogen receptor (ER)

Predictive

Supports Resistance

accepted

EID12045

In this phase III trial (PALOMA-3), patients with ER+, HER2- advanced breast cancer were treated with CDK4/6 inhibitors. Patients were randomized to receive palbociclib plus fulvestrant (P+F) or place… (full text at CIViC)

PMID 30206110 · O'Leary et al., 2018 · Open in CIViC

ESR1 L536Q2
Hormone Therapy	Malignant Breast Neoplasm	Predictive	D	Supports Resistance	3	accepted	EID242 MCF7 cell lines harboring the L536Q mutation in the ligand-binding domain of ESR1 have shown resistance to hormone therapy. PMID 24185512 · Toy et al., 2013 · Open in CIViC	civic
Fulvestrant + TamoxifenSubstitutes	Malignant Breast Neoplasm	Predictive	D	Supports Sensitivity Response	5	accepted	EID290 Using an estrogen response element (ERE)-luciferase reporter system co-transfected with one of five ESR1 mutants, the L536Q ligand binding domain mutation was shown to result in constitutive activity … (full text at CIViC) PMID 24185510 · Robinson et al., 2013 · Open in CIViC	civic

ESR1 L536Q2

Predictive

Supports Resistance

accepted

EID242

MCF7 cell lines harboring the L536Q mutation in the ligand-binding domain of ESR1 have shown resistance to hormone therapy.

PMID 24185512 · Toy et al., 2013 · Open in CIViC

Fulvestrant + TamoxifenSubstitutes

Predictive

Supports Sensitivity Response

accepted

EID290

Using an estrogen response element (ERE)-luciferase reporter system co-transfected with one of five ESR1 mutants, the L536Q ligand binding domain mutation was shown to result in constitutive activity … (full text at CIViC)

PMID 24185510 · Robinson et al., 2013 · Open in CIViC

ESR1 D538G3
Hormone Therapy	Malignant Breast Neoplasm	Predictive	D	Supports Resistance	3	accepted	EID243 MCF7 cell lines harboring the D538G mutation in the ligand-binding domain of ESR1 have shown resistance to hormone therapy. PMID 24185512 · Toy et al., 2013 · Open in CIViC	civic
Letrozole + PalbociclibCombination	Malignant Breast Neoplasm	Predictive	C	Does Not Support Sensitivity Response	2	accepted	EID4814 In a study of 16 patients with metastatic breast cancer (NCT02142868) treated with palbociclib in combination with letrozole, patients with ESR1 mutations (5/16), including ESR1 D538G (n=2), detected … (full text at CIViC) PMID 28978004 · Gyanchandani et al., 2017 · Open in CIViC	civic
Fulvestrant + TamoxifenSubstitutes	Malignant Breast Neoplasm	Predictive	D	Supports Sensitivity Response	5	accepted	EID291 Using an estrogen response element (ERE)-luciferase reporter system co-transfected with one of five ESR1 mutants, the N538G ligand binding domain mutation was shown to result in constitutive activity … (full text at CIViC) PMID 24185510 · Robinson et al., 2013 · Open in CIViC	civic

ESR1 D538G3

Predictive

Supports Resistance

accepted

EID243

MCF7 cell lines harboring the D538G mutation in the ligand-binding domain of ESR1 have shown resistance to hormone therapy.

PMID 24185512 · Toy et al., 2013 · Open in CIViC

Letrozole + PalbociclibCombination

Predictive

Does Not Support Sensitivity Response

accepted

EID4814

In a study of 16 patients with metastatic breast cancer (NCT02142868) treated with palbociclib in combination with letrozole, patients with ESR1 mutations (5/16), including ESR1 D538G (n=2), detected … (full text at CIViC)

PMID 28978004 · Gyanchandani et al., 2017 · Open in CIViC

Fulvestrant + TamoxifenSubstitutes

Predictive

Supports Sensitivity Response

accepted

EID291

Using an estrogen response element (ERE)-luciferase reporter system co-transfected with one of five ESR1 mutants, the N538G ligand binding domain mutation was shown to result in constitutive activity … (full text at CIViC)

PMID 24185510 · Robinson et al., 2013 · Open in CIViC

ESR1 Y537C2
Hormone Therapy	Malignant Breast Neoplasm	Predictive	D	Supports Resistance	3	accepted	EID244 MCF7 cell lines harboring the Y537C mutation in the ligand-binding domain of ESR1 have shown resistance to hormone therapy. PMID 24185512 · Toy et al., 2013 · Open in CIViC	civic
Fulvestrant + TamoxifenSubstitutes	Malignant Breast Neoplasm	Predictive	D	Supports Sensitivity Response	5	accepted	EID292 Using an estrogen response element (ERE)-luciferase reporter system co-transfected with one of five ESR1 mutants, the Y537C ligand binding domain mutation was shown to result in constitutive activity … (full text at CIViC) PMID 24185510 · Robinson et al., 2013 · Open in CIViC	civic

ESR1 Y537C2

Predictive

Supports Resistance

accepted

EID244

MCF7 cell lines harboring the Y537C mutation in the ligand-binding domain of ESR1 have shown resistance to hormone therapy.

PMID 24185512 · Toy et al., 2013 · Open in CIViC

Fulvestrant + TamoxifenSubstitutes

Predictive

Supports Sensitivity Response

accepted

EID292

Using an estrogen response element (ERE)-luciferase reporter system co-transfected with one of five ESR1 mutants, the Y537C ligand binding domain mutation was shown to result in constitutive activity … (full text at CIViC)

PMID 24185510 · Robinson et al., 2013 · Open in CIViC

ESR1 Y537N2
Hormone Therapy	Malignant Breast Neoplasm	Predictive	D	Supports Resistance	3	accepted	EID245 MCF7 cell lines harboring the Y537N mutation in the ligand-binding domain of ESR1 have shown resistance to hormone therapy. PMID 24185512 · Toy et al., 2013 · Open in CIViC	civic
Fulvestrant + TamoxifenSubstitutes	Malignant Breast Neoplasm	Predictive	D	Supports Sensitivity Response	5	accepted	EID293 Using an estrogen response element (ERE)-luciferase reporter system co-transfected with one of five ESR1 mutants, the Y537N ligand binding domain mutation was shown to result in constitutive activity … (full text at CIViC) PMID 24185510 · Robinson et al., 2013 · Open in CIViC	civic

ESR1 Y537N2

Predictive

Supports Resistance

accepted

EID245

MCF7 cell lines harboring the Y537N mutation in the ligand-binding domain of ESR1 have shown resistance to hormone therapy.

PMID 24185512 · Toy et al., 2013 · Open in CIViC

Fulvestrant + TamoxifenSubstitutes

Predictive

Supports Sensitivity Response

accepted

EID293

Using an estrogen response element (ERE)-luciferase reporter system co-transfected with one of five ESR1 mutants, the Y537N ligand binding domain mutation was shown to result in constitutive activity … (full text at CIViC)

PMID 24185510 · Robinson et al., 2013 · Open in CIViC

ESR1 Y537S2
Hormone Therapy	Malignant Breast Neoplasm	Predictive	D	Supports Resistance	3	accepted	EID246 MCF7 cell lines harboring the L537S mutation in the ligand-binding domain of ESR1 have shown resistance to hormone therapy. PMID 24185512 · Toy et al., 2013 · Open in CIViC	civic
Fulvestrant + TamoxifenSubstitutes	Malignant Breast Neoplasm	Predictive	D	Supports Sensitivity Response	5	accepted	EID294 Using an estrogen response element (ERE)-luciferase reporter system co-transfected with one of five ESR1 mutants, the Y537S ligand binding domain mutation was shown to result in constitutive activity … (full text at CIViC) PMID 24185510 · Robinson et al., 2013 · Open in CIViC	civic

ESR1 Y537S2

Predictive

Supports Resistance

accepted

EID246

MCF7 cell lines harboring the L537S mutation in the ligand-binding domain of ESR1 have shown resistance to hormone therapy.

PMID 24185512 · Toy et al., 2013 · Open in CIViC

Fulvestrant + TamoxifenSubstitutes

Predictive

Supports Sensitivity Response

accepted

EID294

Using an estrogen response element (ERE)-luciferase reporter system co-transfected with one of five ESR1 mutants, the Y537S ligand binding domain mutation was shown to result in constitutive activity … (full text at CIViC)

PMID 24185510 · Robinson et al., 2013 · Open in CIViC

ESR1 Overexpression1
Letrozole + PalbociclibCombination	Malignant Breast Neoplasm	Predictive	B	Supports Sensitivity Response	4	accepted	EID1541 A phase 2 clinical trial evaluated 165 patients with oestrogen receptor positive and HER2-negative breast cancer such that 84 patients received combination therapy of palbociclib plus letrozole and 81… (full text at CIViC) PMID 25524798 · Finn et al., 2015 · Open in CIViC	civic

ESR1 Overexpression1

Letrozole + PalbociclibCombination

Predictive

Supports Sensitivity Response

accepted

EID1541

A phase 2 clinical trial evaluated 165 patients with oestrogen receptor positive and HER2-negative breast cancer such that 84 patients received combination therapy of palbociclib plus letrozole and 81… (full text at CIViC)

PMID 25524798 · Finn et al., 2015 · Open in CIViC

ESR1 S463P1
Aromatase Inhibitor	Estrogen Receptor-positive Breast CancerUNRESOLVED	Predictive	D	Supports Resistance	2	accepted	EID1727 ESR1 S463P variants were observed after extensive treatment with hormonal therapy (aromatase inhibition). Expression of the S463P mutant was found to induce modest activity in the absence of hormone. … (full text at CIViC) PMID 24185512 · Toy et al., 2013 · Open in CIViC	civic

ESR1 S463P1

Aromatase Inhibitor

Estrogen Receptor-positive Breast CancerUNRESOLVED

Predictive

Supports Resistance

accepted

EID1727

ESR1 S463P variants were observed after extensive treatment with hormonal therapy (aromatase inhibition). Expression of the S463P mutant was found to induce modest activity in the absence of hormone. … (full text at CIViC)

PMID 24185512 · Toy et al., 2013 · Open in CIViC

Triple-Negative Breast Carcinoma

Drug	Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
Sacituzumab Govitecan	EU EMA	Triple-Negative Breast Carcinoma	Triple-Negative Breast Cancer  Trodelvy is indicated:  as monotherapy for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and who are not candidates for PD-1 or PD-L1 inhibitor therapy (see section 5.1). as monotherapy for the treatment of adult patients with unresectable or metastatic TNBC who have received two or more prior systemic therapies, including at least one of them for advanced disease (see section 5.1)    HR-Positive, HER2-Negative Breast Cancer  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.	approved	Nov 22, 2021	ema
Sacituzumab Govitecan	US FDA	Malignant Breast Neoplasm	Locally Advanced or Metastatic HR-Positive, HER2-Negative Breast Cancer For the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.	approved	Apr 22, 2020	openfda
Tamoxifen	CA Health Canada	—	Marketed in Canada as TAMOXIFENE - 10 (DIN 02296721) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Jul 27, 2011	Oct 29, 2007	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as TAMOXIFENE - 20 (DIN 02296748) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Jul 27, 2011	Oct 29, 2007	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as TAMOXIFEN (DIN 02237596) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Oct 25, 2016	Sep 28, 1999	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as TAMOXIFEN (DIN 02237597) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Oct 25, 2016	Sep 28, 1999	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as PMS-TAMOXIFEN (DIN 02237459) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Oct 28, 2016	Dec 1, 1998	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as PMS-TAMOXIFEN (DIN 02237460) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Oct 28, 2016	Dec 1, 1998	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as TAMONE - (10 MG) (DIN 02063778) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Oct 2, 2007	Dec 31, 1996	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as TAMONE - (20 MG) (DIN 02063751) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Oct 2, 2007	Dec 31, 1996	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as NOLVADEX-D TAB 20MG (DIN 02048485) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Mar 22, 2023	Dec 31, 1995	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as MYLAN-TAMOXIFEN (DIN 02089858) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Jan 9, 2017	Dec 31, 1994	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as MYLAN-TAMOXIFEN (DIN 02088428) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Jan 9, 2017	Dec 31, 1994	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as NOLVADEX TAB 10MG (DIN 02048477) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Apr 1, 2003	Dec 31, 1994	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as TAMOPLEX TAB 20MG (DIN 01951947) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Sep 9, 1996	Dec 31, 1992	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as TAMOPLEX TAB 10MG (DIN 01951939) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Sep 9, 1996	Dec 31, 1992	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as TEVA-TAMOXIFEN (DIN 00851965) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Dec 31, 1990	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as TEVA-TAMOXIFEN (DIN 00851973) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Dec 31, 1990	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as APO-TAMOX TAB 20MG (DIN 00812390) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Dec 31, 1989	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as TAMONE TAB 20MG (DIN 00810452) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Sep 10, 1996	Dec 31, 1989	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as TAMONE TAB 10MG (DIN 00810444) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Sep 10, 1996	Dec 31, 1989	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as APO-TAMOX TAB 10MG (DIN 00812404) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Dec 31, 1989	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as TAMOFEN 10 (DIN 01926624) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Jan 11, 2011	Dec 31, 1986	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as TAMOFEN 20 (DIN 01926632) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Jan 14, 2011	Dec 31, 1986	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as PENTA-TAMOXIFEN TABLETS (DIN 02232552) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled (Unreturned Annual)since Apr 5, 2018	—	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as PENTA-TAMOXIFEN TABLETS (DIN 02232551) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled (Unreturned Annual)since Apr 5, 2018	—	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as DOM-TAMOXIFEN (DIN 02237598) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Oct 25, 2016	—	health-canada-dpd
Tamoxifen	CA Health Canada	—	Marketed in Canada as DOM-TAMOXIFEN (DIN 02237599) under ATC L02BA01 TAMOXIFEN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Oct 25, 2016	—	health-canada-dpd
Tamoxifen	US FDA	—	Efficacy supplement 2018-09-25 (see label)	approved	Sep 25, 2018	openfda
Tamoxifen	US FDA	—	To reduce risk of invasive breast cancer following breast surgery and radiation in adult women with ductal carcinoma in situ (DCIS)	approved	Oct 29, 2005	openfda
Tamoxifen	US FDA	Malignant Breast Neoplasm	For treatment of adult patients with estrogen receptor-positive metastatic breast cancer	approved	Oct 29, 2005	openfda
Tamoxifen	US FDA	Malignant Breast Neoplasm	For adjuvant treatment of adult patients with early stage estrogen receptor- positive breast cancer	approved	Oct 29, 2005	openfda
Tamoxifen	US FDA	Malignant Breast Neoplasm	To reduce the incidence of breast cancer in adult women at high risk	approved	Oct 29, 2005	openfda
Trastuzumab	EU EMA	—	Breast cancer Metastatic breast cancer Dazublys is indicated for the treatment of adult patients with HER2-positive metastatic breast cancer (MBC): as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor-positive patients must also have failed hormonal therapy unless patients are unsuitable for these treatments. in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable. in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease. in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor-positive MBC, not previously treated with trastuzumab. Early breast cancer Dazublys is indicated for the treatment of adult patients with HER2-positive early breast cancer. (EBC). following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) (see section 5.1). following adjuvant chemotherapy with doxorubicin and cyclophosphamide in combination with paclitaxel or docetaxel. in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin. in combination with neoadjuvant chemotherapy followed by adjuvant Dazublys therapy for locally advanced (including inflammatory) disease or tumors> 2 cm in diameter (see sections 4.4 and 5.1). Dazublys should only be used in patients with metastatic or early breast cancer whose tumors have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay (see sections 4.4 and 5.1). Metastatic gastric cancer Dazublys in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease. Dazublys should only be used in patients with metastatic gastric cancer (MGC) whose tumors have HER2 overexpression as defined by IHC2+ and a confirmatory SISH or FISH result or by an IHC 3+ result. Accurate and validated assay methods should be used (see sections 4.4 and 5.1).	approved	Jun 30, 2025	ema
Trastuzumab Deruxtecan	US FDA	Malignant Breast Neoplasm	HER2-Low and HER2-Ultralow Metastatic Breast Cancer as monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA-authorized test, that has progressed on one or more endocrine therapies in the metastatic setting.	approved	Dec 20, 2019	openfda
Trastuzumab Deruxtecan	US FDA	Malignant Breast Neoplasm	HER2-Low and HER2-Ultralow Metastatic Breast Cancer as monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA-authorized test, that has progressed on one or more endocrine therapies in the metastatic setting.	approved	Dec 20, 2019	openfda

Drug

Jurisdiction · authority

Cancer

Indication

Status

Approval date

Source

Sacituzumab Govitecan

EU EMA

Triple-Negative Breast Cancer  Trodelvy is indicated:  as monotherapy for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and who are not candidates for PD-1 or PD-L1 inhibitor therapy (see section 5.1). as monotherapy for the treatment of adult patients with unresectable or metastatic TNBC who have received two or more prior systemic therapies, including at least one of them for advanced disease (see section 5.1)    HR-Positive, HER2-Negative Breast Cancer  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.

approved

Nov 22, 2021

ema

Sacituzumab Govitecan

US FDA