| Abiraterone | EU EMA | Castration-Resistant Prostate Carcinoma | Abiraterone Accord is indicated with prednisone or prednisolone for: the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT) the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen. | approved | Apr 26, 2021 | ema |
| Abiraterone | EU EMA | Castration-Resistant Prostate Carcinoma | Zytiga is indicated with prednisone or prednisolone for: the treatment of metastatic castration resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated the treatment of metastatic castration resistant prostate cancer in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.accelerated | approved | Sep 5, 2011 | ema |
| Abiraterone Acetate | EU EMA | Malignant Prostate Neoplasm | Treatment of adult patients with prostate cancer. | approved | Apr 19, 2023 | ema |
| Abiraterone Acetate | EU EMA | Castration-Resistant Prostate Carcinoma | Abiraterone Mylan is indicated with prednisone or prednisolone for: the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT). the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated. the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen. | approved | Aug 20, 2021 | ema |
| Abiraterone Acetate | EU EMA | Castration-Resistant Prostate Carcinoma | Abiraterone Krka is indicated with prednisone or prednisolone for: the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT) (see section 5.1) the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1) the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen. | approved | Jun 24, 2021 | ema |
| Apalutamide | EU EMA | Nonmetastatic Castration-Resistant Prostate Carcinoma | Erleada is indicated: in adult men for the treatment of non metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease. in adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT). | approved | Jan 14, 2019 | ema |
| Autologous peripheral-blood mononuclear cells activated with prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor | EU EMA | Malignant Prostate Neoplasm | Provenge is indicated for treatment of asymptomatic or minimally symptomatic metastatic (non-visceral) castrate-resistant prostate cancer in male adults in whom chemotherapy is not yet clinically indicated. | withdrawnsince May 6, 2015 | Sep 6, 2013 | ema |
| Cabazitaxel | EU EMA | Malignant Prostate Neoplasm | Treatment of patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen. | approved | Aug 28, 2020 | ema |
| Cabazitaxel | EU EMA | Malignant Prostate Neoplasm | Jevtana in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen. | approved | Mar 17, 2011 | ema |
| Darolutamide | EU EMA | Nonmetastatic Castration-Resistant Prostate Carcinoma | NUBEQA is indicated for the treatment of adult men with non‑metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease (see section 5.1). metastatic hormone‑sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (see section 5.1). metastatic hormone‑sensitive prostate cancer (mHSPC) in combination with docetaxel and androgen deprivation therapy (see section 5.1). | approved | Mar 27, 2020 | ema |
| Degarelix | EU EMA | Malignant Prostate Neoplasm | Degarelix Accord is a gonadotrophin releasing hormone (GnRH) antagonist indicated: for treatment of adult male patients with advanced hormone-dependent prostate cancer. for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy. as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer. | approved | Sep 29, 2023 | ema |
| Degarelix | EU EMA | Malignant Prostate Neoplasm | FIRMAGON is a gonadotrophin releasing hormone (GnRH) antagonist indicated: - for treatment of adult male patients with advanced hormone-dependent prostate cancer. - for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy. - as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer. | approved | Feb 17, 2009 | 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 |
| Enzalutamide | EU EMA | Castration-Resistant Prostate Carcinoma | Enzalutamide Viatris is indicated:• as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage-radiotherapy (see section 5.1);• in combination with androgen deprivation therapy for the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) (see section 5.1); • for the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1);• for the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1);• for the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy. | approved | Aug 22, 2024 | ema |
| Enzalutamide | EU EMA | Castration-Resistant Prostate Carcinoma | Xtandi is indicated for: as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high risk biochemical recurrent (BCR) non-metastatic hormone sensitive prostate cancer (nmHSPC) who are unsuitable for salvage radiotherapy (see section 5.1). the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (see section 5.1). the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1). the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1). the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy. | approved | Jun 21, 2013 | ema |
| Enzalutamide | EU EMA | Malignant Prostate Neoplasm | Treatment of prostate cancer. | approved | — | 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 |
| Leuprolide | EU EMA | Malignant Prostate Neoplasm | Camcevi is indicated for the treatment of hormone dependent advanced prostate cancer and for the treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy. | approved | May 24, 2022 | ema |
| Niraparib | EU EMA | Malignant Prostate Neoplasm | Treatment of adult patients with prostate cancer. | approved | Apr 19, 2023 | ema |
| Padeliporfin | EU EMA | Prostate Adenocarcinoma | Tookad is indicated as monotherapy for adult patients with previously untreated, unilateral, low risk, adenocarcinoma of the prostate with a life expectancy ? 10 years and: Clinical stage T1c or T2a; Gleason Score ? 6, based on high-resolution biopsy strategies; PSA ? 10 ng/mL; 3 positive cancer cores with a maximum cancer core length of 5 mm in any one core or 1-2 positive cancer cores with ? 50 % cancer involvement in any one core or a PSA density ? 0.15 ng/mL/cm³. | approved | Nov 10, 2017 | ema |
| Radium Ra223 dichloride | EU EMA | Castration-Resistant Prostate Carcinoma | Xofigo is indicated for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases. | approved | Nov 13, 2013 | ema |
| Relugolix | EU EMA | Malignant Prostate Neoplasm | Orgovyx is indicated for the treatment of adult patients with advanced hormone-sensitive prostate cancer. | approved | Apr 29, 2022 | 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 |
| 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 |