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Darolutamide: First Approval

delete2019-10-11
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Anthony Markham *
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Sean T. Duggan
DOI:10.1007/s40265-019-01212-ydelete
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Abstract

Abstract

En 中文
Darolutamide (NUBEQA (TM)) is a structurally distinct non-steroidal androgen receptor antagonist being developed by Orion and Bayer as a treatment for prostate cancer. Based on positive results in the phase III ARAMIS trial, darolutamide was recently approved in the USA for the treatment of men with non-metastatic castration-resistant prostate cancer. This article summarizes the milestones in the development of darolutamide leading to this first approval.
Keywords:
ODM-201
SAFETY
ARADES
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Drugs cover
Drugs
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14.4
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Cited Papers

Cited Papers

Pharmacokinetics, Antitumor Activity, and Safety of ODM-201 in Patients with Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer: An Open-label Phase 1 Study
err2016-05-01
err56
errOAAI
errMassard, Christophe; Penttinen, Heidi M.; Vjaters, Egils; Bono, Petri; Lietuvietis, Vilnis; Tammela, Teuvo L.; Vuorela, Annamari; Nykanen, Pirjo; Pohjanjousi, Pasi; Snapir, Amir; Fizazi, Karim
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Evaluation of Clinically Relevant Drug-Drug Interactions and Population Pharmacokinetics of Darolutamide in Patients with Nonmetastatic Castration-Resistant Prostate Cancer: Results of Pre-Specified and Post Hoc Analyses of the Phase III ARAMIS Trial
err2019-09-30
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errShore, Neal; Zurth, Christian; Fricke, Robert; Gieschen, Hille; Graudenz, Kristina; Koskinen, Mikko; Ploeger, Bart; Moss, Jonathan; Prien, Olaf; Borghesi, Gustavo; Petrenciuc, Oana; Tammela, Teuvo L.; Kuss, Iris; Verholen, Frank; Smith, Matthew R.; Fizazi, Karim
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Safety and Antitumour Activity of ODM-201 (BAY-1841788) in Chemotherapy-naive and CYP17 Inhibitor-naive Patients: Follow-up from the ARADES and ARAFOR Trials
err2018-07-01
err35
errOAAI
errShore, Neal D.; Tammela, Teuvo L.; Massard, Christophe; Bono, Petri; Aspegren, John; Mustonen, Mika; Fizazi, Karim
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Darolutamide is a potent androgen receptor antagonist with strong efficacy in prostate cancer models
err2019-03-23
err64
errOAAI
errSugawara, Tatsuo; Baumgart, Simon J.; Nevedomskaya, Ekaterina; Reichert, Kristin; Steuber, Holger; Lejeune, Pascale; Mumberg, Dominik; Haendler, Bernard
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Structure and composition of the neutral upper atmosphere of Mars from the MAVEN NGIMS investigation
err2015-11-05
err0
errOAAI
errP. R. Mahaffy; M. Benna; M. Elrod; R. V. Yelle; S. W. Bougher; S. W. Stone; B. M. Jakosky
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Discovery of ODM-201, a new-generation androgen receptor inhibitor targeting resistance mechanisms to androgen signaling-directed prostate cancer therapies
err2015-07-03
err313
errOAAI
errMoilanen, Anu-Maarit; Riikonen, Reetta; Oksala, Riikka; Ravanti, Laura; Aho, Eija; Wohlfahrt, Gerd; Nykanen, Pirjo S.; Tormakangas, Olli P.; Palvimo, Jorma J.; Kallio, Pekka J.
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Decreased insulin sensitivity and abnormal glucose metabolism start in preadolescence in low-birth-weight children—Meta-analysis and systematic review
err2019-10-01
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errYiwen Xu; Shi Chen; Hongbo Yang; Fengying Gong; Linjie Wang; Yu Jiang; Chengsheng Yan; Huijuan Zhu; Hui Pan
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