| Abemaciclib | EU EMA | Malignant Breast Neoplasm | Early Breast Cancer 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). In pre or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. Advanced or Metastatic Breast Cancer 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. In pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist. | approved | Sep 26, 2018 | ema |
| Alpelisib | EU EMA | Malignant Breast Neoplasm | 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 endocrine therapy as monotherapy (see section 5.1). | approved | Jul 27, 2020 | ema |
| Capivasertib | EU EMA | Malignant Breast Neoplasm | 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. In pre- or perimenopausal women, Truqap plus fulvestrant should be combined with a luteinising hormone releasing hormone (LHRH) agonist. For men, administration of LHRH agonist according to current clinical practice standards should be considered. | approved | Jun 17, 2024 | ema |
| Datopotamab Deruxtecan | EU EMA | Malignant Breast Neoplasm | Breast cancerDatroway 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. | approved | Apr 4, 2025 | ema |
| Doxorubicin | EU EMA | Malignant Breast Neoplasm | Myocet liposomal, in combination with cyclophosphamide, is indicated for the first-line treatment of metastatic breast cancer in adult women. | approved | Jul 13, 2000 | ema |
| Elacestrant | EU EMA | Malignant Breast Neoplasm | 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. | approved | Sep 15, 2023 | ema |
| Entrectinib | EU EMA | Tumor-agnosticLung Non-Small Cell Carcinoma | Rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have not received a prior NTRK inhibitor who have no satisfactory treatment options. Rozlytrek as monotherapy is indicated for the treatment of adult patients with ROS1 positive, advanced non small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.conditional | approved | Jul 31, 2020 | ema |
| Fulvestrant | EU EMA | Malignant Breast Neoplasm | Fulvestrant is indicated 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 anti-estrogen therapy, or disease progression on antiestrogen therapy. | approved | Jan 8, 2018 | ema |
| Fulvestrant | EU EMA | Malignant Breast Neoplasm | Faslodex is indicated 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. 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. In pre- or perimenopausal women, the combination treatment with palbociclib should be combined with a luteinizing hormone releasing hormone (LHRH) agonist. | approved | Mar 9, 2004 | ema |
| Imlunestrant | EU EMA | Malignant Breast Neoplasm | 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).In pre- or perimenopausal women, or men, Inluriyo should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. | approved | Jan 9, 2026 | ema |
| Inavolisib | EU EMA | Malignant Breast Neoplasm | 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). Patients previously treated with a CDK 4/6 inhibitor in the (neo)adjuvant setting should have had an interval of at least 12 months between termination of CDK 4/6 inhibitor treatment and the detection of recurrence. In pre/perimenopausal women and in men, endocrine therapy should be combined with a luteinising hormone releasing hormone (LHRH) agonist. | approved | Jul 18, 2025 | ema |
| Lapatinib | EU EMA | Malignant Breast Neoplasm | Tyverb is indicated for the treatment of patients with breast cancer, whose tumours overexpress HER2 (ErbB2): in combination with capecitabine for patients with advanced or metastatic disease with progression following prior therapy, which must have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting; in combination with trastuzumab for patients with hormone-receptor-negative metastatic disease that has progressed on prior trastuzumab therapy or therapies in combination with chemotherapy; in combination with an aromatase inhibitor for post-menopausal women with hormone-receptor-positive metastatic disease, not currently intended for chemotherapy. The patients in the registration study had not previously been treated with trastuzumab or an aromatase inhibitor. No data are available on the efficacy of this combination relative to trastuzumab in combination with an aromatase inhibitor in this patient population. | approved | Jun 10, 2008 | ema |
| Larotrectinib | EU EMA | Tumor-agnostic | Vitrakvi as monotherapy is indicated for the treatment of adult and paediatric patients with solid tumours that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory treatment options.conditional | approved | Sep 19, 2019 | ema |
| Neratinib | EU EMA | Malignant Breast Neoplasm | Nerlynx is indicated for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who are less than one year from the completion of prior adjuvant trastuzumab based therapy. | approved | Aug 31, 2018 | ema |
| Palbociclib | EU EMA | Malignant Breast Neoplasm | Palbociclib Viatris 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; in combination with fulvestrant in women who have received prior endocrine therapy (see section 5.1). In pre‑ or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone‑releasing hormone (LHRH) agonist. | approved | Jun 19, 2026 | ema |
| Palbociclib | EU EMA | Malignant Breast Neoplasm | 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; in combination with fulvestrant in women who have received prior endocrine therapy. In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone releasing hormone (LHRH) agonist. | approved | Nov 9, 2016 | ema |
| Pertuzumab | EU EMA | Early Stage Breast Carcinoma | Early breast cancerPoherdy is indicated for use in combination with trastuzumab and chemotherapy in:- the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence- the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrenceMetastatic breast cancerPoherdy is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease. | approved | Apr 23, 2026 | ema |
| Pertuzumab | EU EMA | Early Stage Breast Carcinoma | Early breast cancer (EBC) Phesgo is indicated for use in combination with chemotherapy in: the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence Metastatic breast cancer (MBC) Phesgo is indicated for use in combination with docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease. | approved | Dec 21, 2020 | ema |
| Pertuzumab | EU EMA | Early Stage Breast Carcinoma | Metastatic Breast Cancer: Perjeta is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease. Neoadjuvant Treatment of Breast Cancer: Perjeta is indicated for use in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence. | approved | Mar 4, 2013 | ema |
| Repotrectinib | EU EMA | Tumor-agnosticLung Non-Small Cell Carcinoma | Augtyro as monotherapy is indicated for the treatment of adult patients with ROS1-positive advanced non-small cell lung cancer (NSCLC). Augtyro as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with advanced solid tumours expressing a NTRK gene fusion, and who have received a prior NTRK inhibitor, or have not received a prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit, or have been exhausted (see sections 4.4 and 5.1)conditional | approved | Jan 13, 2025 | ema |
| Ribociclib | EU EMA | Malignant Breast Neoplasm | Early breast cancer 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). In pre- or perimenopausal women, or in men, the aromatase inhibitor should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. Advanced or metastatic breast cancer 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. In pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist. | approved | Aug 22, 2017 | ema |
| 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 |
| Selpercatinib | EU EMA | Tumor-agnostic | Retsevmo as monotherapy is indicated for the treatment of adults with: advanced RET fusion positive non small cell lung cancer (NSCLC) not previously treated with a RET inhibitor. For biomarker-based patient selection, see section 4.2. Retsevmo as monotherapy is indicated for the treatment of adults and paediatric patients 2 years of age and older with: advanced RET fusion positive thyroid cancer who are radioactive iodine-refractory (if radioactive iodine is appropriate) . For biomarker-based patient selection, see section 4.2. advanced RET mutant medullary thyroid cancer (MTC) . For biomarker-based patient selection, see section 4.2. advanced RET fusion positive solid tumours, when treatment options not targeting RET provide limited clinical benefit, or have been exhausted (see sections 4.4 and 5.1). For biomarker-based patient selection, see section 4.2. | approved | Feb 11, 2021 | ema |
| Toremifene | EU EMA | Malignant Breast Neoplasm | First line hormone treatment of hormone-dependent metastatic breast cancer in postmenopausal patients.Fareston is not recommended for patients with estrogen receptor negative tumours. | approved | Feb 14, 1996 | ema |
| Trastuzumab | EU EMA | Early Stage Breast Carcinoma | Early breast cancer (EBC) Phesgo is indicated for use in combination with chemotherapy in: the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence Metastatic breast cancer (MBC) Phesgo is indicated for use in combination with docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease. | approved | Dec 21, 2020 | ema |
| Trastuzumab Emtansine | EU EMA | Malignant Breast Neoplasm | Early Breast Cancer (EBC) Kadcyla, as a single agent, is indicated for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy. Metastatic Breast Cancer (MBC) Kadcyla, as a single agent, is indicated for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either: Received prior therapy for locally advanced or metastatic disease, or Developed disease recurrence during or within six months of completing adjuvant therapy. | approved | Nov 15, 2013 | ema |
| Tucatinib | EU EMA | Malignant Breast Neoplasm | Tukysa is indicated in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2?positive locally advanced or metastatic breast cancer who have received at least 2 prior anti-HER2 treatment regimens. | approved | Feb 11, 2021 | ema |