Human medicines European public assessment report (EPAR): Erleada, apalutamide, Date of authorisation: 14/01/2019, Revision: 22, Status: Authorised

Erleada RSS Authorised This medicine is authorised for use in the European Union apalutamide Medicine Human Authorised Application under evaluation CHMP opinion European Commission decision Overview Erleada is a cancer medicine used to treat men with cancer of the prostate (a gland of the male reproductive system). It is used when the cancer is not responding to treatments that lower testosterone levels (castration resistant) and is at high risk of spreading to other parts of the body. It is also used when the cancer has spread to other parts of the body (metastatic) but responds to treatment that lowers testosterone levels (hormone sensitive). Erleada is used in combination with a treatment called androgen deprivation therapy. Erleada contains the active substance apalutamide. Expand section Collapse section How is Erleada used? Erleada is available as tablets (60 mg) to be taken by mouth. The recommended dose is 4 tablets (240 mg) a day. Treatment may have to be temporarily interrupted if the patient experiences intolerable side effects. Erleada can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the treatment of prostate cancer. For more information about using Erleada, see the package leaflet or contact your doctor or pharmacist. How does Erleada work? The active substance in Erleada, apalutamide, works by blocking the action of testosterone and other male hormones known as androgens. It does this by blocking the receptors (targets) to which these hormones attach. Because prostate cancer cells need testosterone and other male hormones to survive and grow, by blocking the effects of these hormones, apalutamide slows down the growth of the cancer. What benefits of Erleada have been shown in studies? In a main study involving 1,207 patients with non-metastatic, castration-resistant prostate cancer, Erleada was shown to be more effective than placebo (a dummy treatment) at prolonging the time patients lived without the disease spreading to other parts of the body: patients on Erleada lived on average for 41 months without the disease spreading, compared with 16 months for patients taking placebo. Both Erleada and placebo were given with a treatment called androgen deprivation therapy. In another main study involving 1,052 patients with metastatic, hormone-sensitive prostate cancer, Erleada in combination with androgen deprivation therapy was effective at delaying worsening of the disease: after 2 years, the disease did not get worse in 68% of patients receiving Erleada and androgen deprivation therapy compared with 48% of those who received placebo with androgen deprivation therapy. After 2 years, 82% of patients given Erleada were alive compared with 74% of those in the placebo group. What are the risks associated with Erleada? The most common side effects with Erleada (which may affect more than 1 in 10 people) are tiredness, skin rash, hypertension (high blood pressure), hot flushes, joint pain, diarrhoea, falls, fractures (broken bones) and weight loss. For the full list of side effects of Erleada, see the package leaflet. Erleada must not be used by women who are pregnant or may become pregnant. For the full list of restrictions, see the package leaflet. Why is Erleada authorised in the EU? Erleada is effective at delaying the spread of prostate cancer that is not responding to testosterone-lowering treatments and is at high risk of spreading to other parts of the body. It is also effective at delaying the worsening of the disease in patients whose cancer has spread to other parts of the body and is sensitive to hormones. Although more data are needed on its effects on prolonging patients’ life, the benefits seen so far are considered important. Regarding its safety, the side effects with Erleada were considered manageable. The European Medicines Agency therefore decided that Erleada’s benefits are greater than its risks and it can be authorised for use in the EU. What measures are being taken to ensure the safe and effective use of Erleada? In order to further evaluate the effectiveness of Erleada, the company that markets the medicine has to submit the final results of the main study, including data on the effects of the medicine on prolonging patients’ life. Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Erleada have also been included in the summary of product characteristics and the package leaflet. As for all medicines, data on the use of Erleada are continuously monitored. Side effects reported with Erleada are carefully evaluated and any necessary action taken to protect patients. Other information about Erleada Erleada received a marketing authorisation valid throughout the EU on 14 January 2019. Erleada : EPAR - Medicine overview Reference Number: EMA/810516/2018 English (EN) (122.39 KB - PDF) First published: 19/03/2019 View Other languages (22) български (BG) (144.88 KB - PDF) First published: 19/03/2019 View español (ES) (121.81 KB - PDF) First published: 19/03/2019 View čeština (CS) (142.8 KB - PDF) First published: 19/03/2019 View dansk (DA) (120.42 KB - PDF) First published: 19/03/2019 View Deutsch (DE) (124.16 KB - PDF) First published: 19/03/2019 View eesti keel (ET) (108.9 KB - PDF) First published: 19/03/2019 View ελληνικά (EL) (143.24 KB - PDF) First published: 19/03/2019 View français (FR) (122.83 KB - PDF) First published: 19/03/2019 View hrvatski (HR) (141.76 KB - PDF) First published: 19/03/2019 View italiano (IT) (120.35 KB - PDF) First published: 19/03/2019 View latviešu valoda (LV) (159.39 KB - PDF) First published: 19/03/2019 View lietuvių kalba (LT) (140.97 KB - PDF) First published: 19/03/2019 View magyar (HU) (141.05 KB - PDF) First published: 19/03/2019 View Malti (MT) (145.98 KB - PDF) First published: 19/03/2019 View Nederlands (NL) (120.95 KB - PDF) First published: 19/03/2019 View polski (PL) (144.26 KB - PDF) First published: 19/03/2019 View português (PT) (122.14 KB - PDF) First published: 19/03/2019 View română (RO) (140.21 KB - PDF) First published: 19/03/2019 View slovenčina (SK) (143.48 KB - PDF) First published: 19/03/2019 View slovenščina (SL) (140.68 KB - PDF) First published: 19/03/2019 View Suomi (FI) (118.99 KB - PDF) First published: 19/03/2019 View svenska (SV) (121.8 KB - PDF) First published: 19/03/2019 View Erleada : EPAR - Risk-management-plan English (EN) (383.79 KB - PDF) First published: 09/01/2025 Last updated: 31/03/2026 View Product information Erleada : EPAR - Product information English (EN) (1.4 MB - PDF) First published: 19/03/2019 Last updated: 31/03/2026 View Other languages (24) български (BG) (868.52 KB - PDF) First published: 19/03/2019 Last updated: 31/03/2026 View español (ES) (983.02 KB - PDF) First published: 19/03/2019 Last updated: 31/03/2026 View čeština (CS) (1.07 MB - PDF) First published: 19/03/2019 Last updated: 31/03/2026 View dansk (DA) (1.3 MB - PDF) First published: 19/03/2019 Last updated: 31/03/2026 View Deutsch (DE) (1.23 MB - PDF) First published: 19/03/2019 Last updated: 31/03/2026 View eesti keel (ET) (1.23 MB - PDF) First published: 19/03/2019 Last updated: 31/03/2026 View ελληνικά (EL) (1.38 MB - PDF) First published: 19/03/2019 Last updated: 31/03/2026 View français (FR) (1.53 MB - PDF) First published: 19/03/2019 Last updated: 31/03/2026 View hrvatski (HR) (1.27 MB - PDF) First published: 19/03/2019 Last updated: 31/03/2026 View íslenska (IS) (1.18 MB - PDF) First published: 19/03/2019 Last updated: 31/03/2026 View italiano (IT) (1.35 MB - PDF) First published: 19/03/2019 Last updated: 31/03/2026 View latviešu valoda (LV) (2.92 MB - PDF) First published: 19/03/2019 Last updated: 31/03/2026 View lietuvių kalba (LT) (1.64 MB - PDF) First published: 19/03/2019 Last updated: 31/03/2026 View magyar (HU) (886.55 KB - PDF) First published: 19/03/2019 Last updated: 31/03/2026 View Malti (MT) (1.07 MB - PDF) First published: 19/03/2019 Last updated: 31/03/2026 View Nederlands (NL) (1.22 MB - PDF) First published: 19/03/2019 Last updated: 31/03/2026 View norsk (NO) (1.33 MB - PDF) First published: 19/03/2019 Last updated: 31/03/2026 View polski (PL) (1.57 MB - PDF) First published: 19/03/2019 Last updated: 31/03/2026 View português (PT) (1.34 MB - PDF) First published: 19/03/2019 Last updated: 31/03/2026 View română (RO) (862.7 KB - PDF) First published: 19/03/2019 Last updated: 31/03/2026 View slovenčina (SK) (1008.97 KB - PDF) First published: 19/03/2019 Last updated: 31/03/2026 View slovenščina (SL) (960.08 KB - PDF) First published: 19/03/2019 Last updated: 31/03/2026 View Suomi (FI) (891.93 KB - PDF) First published: 19/03/2019 Last updated: 31/03/2026 View svenska (SV) (1.11 MB - PDF) First published: 19/03/2019 Last updated: 31/03/2026 View Latest procedure affecting product information: VR/0000296280 26/03/2026 This medicine’s product information is available in all official EU languages . Select 'available languages' to access the language you need. Product information documents contain: summary of product characteristics (annex I); manufacturing authorisation holder responsible for batch release (annex IIA); conditions of the marketing authorisation (annex IIB); labelling (annex IIIA); package leaflet (annex IIIB). Erleada : EPAR - All authorised presentations English (EN) (30.98 KB - PDF) First published: 19/03/2019 Last updated: 08/07/2025 View Other languages (24) български (BG) (32.71 KB - PDF) First published: 19/03/2019 Last updated: 08/07/2025 View español (ES) (31.07 KB - PDF) First published: 19/03/2019 Last updated: 08/07/2025 View čeština (CS) (32.11 KB - PDF) First published: 19/03/2019 Last updated: 08/07/2025 View dansk (DA) (31.19 KB - PDF) First published: 19/03/2019 Last updated: 08/07/2025 View Deutsch (DE) (25.77 KB - PDF) First published: 19/03/2019 Last updated: 08/07/2025 View eesti keel (ET) (24.84 KB - PDF) First published: 19/03/2019 Last updated: 08/07/2025 View ελληνικά (EL) (33.12 KB - PDF) First published: 19/03/2019 Last updated: 08/07/2025 View français (FR) (30.52 KB - PDF) First published: 19/03/2019 Last updated: 08/07/2025 View hrvatski (HR) (29.91 KB - PDF) First published: 19/03/2019 Last updated: 08/07/2025 View íslenska (IS) (30.99 KB - PDF) First published: 19/03/2019 Last updated: 08/07/2025 View italiano (IT) (30.86 KB - PDF) First published: 19/03/2019 Last updated: 08/07/2025 View latviešu valoda (LV) (25.8 KB - PDF) First published: 19/03/2019 Last updated: 08/07/2025 View lietuvių kalba (LT) (26.01 KB - PDF) First published: 19/03/2019 Last updated: 08/07/2025 View magyar (HU) (31.93 KB - PDF) First published: 19/03/2019 Last updated: 08/07/2025 View Malti (MT) (32.14 KB - PDF) First published: 19/03/2019 Last updated: 08/07/2025 View Nederlands (NL) (30.24 KB - PDF) First published: 19/03/2019 Last updated: 08/07/2025 View norsk (NO) (31.41 KB - PDF) First published: 19/03/2019 Last updated: 08/07/2025 View polski (PL) (31.7 KB - PDF) First published: 19/03/2019 Last updated: 08/07/2025 View português (PT) (31.51 KB - PDF) First published: 19/03/2019 Last updated: 08/07/2025 View română (RO) (30.74 KB - PDF) First published: 19/03/2019 Last updated: 08/07/2025 View slovenčina (SK) (32.18 KB - PDF) First published: 19/03/2019 Last updated: 08/07/2025 View slovenščina (SL) (31.32 KB - PDF) First published: 19/03/2019 Last updated: 08/07/2025 View Suomi (FI) (30.66 KB - PDF) First published: 19/03/2019 Last updated: 08/07/2025 View svenska (SV) (30.2 KB - PDF) First published: 19/03/2019 Last updated: 08/07/2025 View Product details Name of medicine Erleada Active substance apalutamide International non-proprietary name (INN) or common name apalutamide Therapeutic area (MeSH) Prostatic Neoplasms Anatomical therapeutic chemical (ATC) code L02BB05 Pharmacotherapeutic group Endocrine therapy Therapeutic indication 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). Authorisation details EMA product number EMEA/H/C/004452 Marketing authorisation holder Janssen-Cilag International NV Turnhoutseweg 30 B-2340 Beerse Belgium Opinion adopted 15/11/2018 Marketing authorisation issued 14/01/2019 Revision 22 Assessment history Expand section Collapse section Changes since initial authorisation of medicine Erleada : EPAR - Procedural steps taken and scientific information after authorisation English (EN) (191.18 KB - PDF) First published: 19/11/2025 Last updated: 31/03/2026 View Erleada : EPAR - Procedural steps taken and scientific information after authorisation (archive) English (EN) (245.11 KB - PDF) First published: 18/02/2020 Last updated: 19/11/2025 View Erleada-PSUSA-00010745-202502 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation Reference Number: EMADOC-1700519818-2680341 English (EN) (116.15 KB - PDF) First published: 01/12/2025 View Erleada-H-C-PSUSA-00010745-202402 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation Adopted Reference Number: EMA/563609/2024 English (EN) (110.36 KB - PDF) First published: 04/12/2024 View Erleada-H-C-PSUSA-00010745-202302 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation Reference Number: EMA/CHMP/10331/2024 English (EN) (187.01 KB - PDF) First published: 09/01/2024 View Erleada-H-C-004452-X-0028-G : EPAR - Assessment report - Extension Adopted Reference Number: EMA/317740/2023 English (EN) (1.09 MB - PDF) First published: 22/09/2023 View Erleada-H-C-PSUSA-00010745-202202 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation Adopted Reference Number: EMA/129416/2023 English (EN) (105.77 KB - PDF) First published: 20/03/2023 View Erleada-H-C-4452-II-0001 : EPAR - Assessment Report - Variation Adopted Reference Number: EMA/CHMP/3945/2020 English (EN) (5.86 MB - PDF) First published: 06/03/2020 View CHMP post-authorisation summary of positive opinion for Erleada (II-01) Adopted Reference Number: EMA/CHMP/672735/2019 English (EN) (136.99 KB - PDF) First published: 13/12/2019 View Initial marketing authorisation documents Erleada : EPAR - Public assessment report Adopted Reference Number: EMA/879617/2018 English (EN) (7.96 MB - PDF) First published: 21/03/2019 View CHMP summary of positive opinion for Erleada Adopted Reference Number: EMA/CHMP/784876/2018 English (EN) (61.01 KB - PDF) First published: 16/11/2018 View News on Erleada Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 December 2019 13/12/2019 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 November 2018 16/11/2018 Topics Medicines This page was last updated on 31/03/2026 Share this page