Literature DB >> 31605368

Darolutamide: First Approval.

Anthony Markham1, Sean Duggan2.   

Abstract

Darolutamide (NUBEQA™) 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.

Entities:  

Year:  2019        PMID： 31605368     DOI： 10.1007/s40265-019-01212-y

Source DB:  PubMed          Journal:  Drugs        ISSN： 0012-6667            Impact factor:   9.546


  9 in total

Review 1.  Clinical Development of Darolutamide: A Novel Androgen Receptor Antagonist for the Treatment of Prostate Cancer.

Authors:  Karim Fizazi; Matthew R Smith; Bertrand Tombal
Journal:  Clin Genitourin Cancer       Date:  2018-07-24       Impact factor: 2.872

2.  Safety and Antitumour Activity of ODM-201 (BAY-1841788) in Chemotherapy-naïve and CYP17 Inhibitor-naïve Patients: Follow-up from the ARADES and ARAFOR Trials.

Authors:  Neal D Shore; Teuvo L Tammela; Christophe Massard; Petri Bono; John Aspegren; Mika Mustonen; Karim Fizazi
Journal:  Eur Urol Focus       Date:  2017-02-14

3.  Pharmacokinetics, Antitumor Activity, and Safety of ODM-201 in Patients with Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer: An Open-label Phase 1 Study.

Authors:  Christophe Massard; Heidi M Penttinen; Egils Vjaters; Petri Bono; Vilnis Lietuvietis; Teuvo L Tammela; Annamari Vuorela; Pirjo Nykänen; Pasi Pohjanjousi; Amir Snapir; Karim Fizazi
Journal:  Eur Urol       Date:  2015-10-17       Impact factor: 20.096

4.  Activity and safety of ODM-201 in patients with progressive metastatic castration-resistant prostate cancer (ARADES): an open-label phase 1 dose-escalation and randomised phase 2 dose expansion trial.

Authors:  Karim Fizazi; Christophe Massard; Petri Bono; Robert Jones; Vesa Kataja; Nicholas James; Jorge A Garcia; Andrew Protheroe; Teuvo L Tammela; Tony Elliott; Leena Mattila; John Aspegren; Annamari Vuorela; Peter Langmuir; Mika Mustonen
Journal:  Lancet Oncol       Date:  2014-06-25       Impact factor: 41.316

5.  Darolutamide in Nonmetastatic, Castration-Resistant Prostate Cancer.

Authors:  Karim Fizazi; Neal Shore; Teuvo L Tammela; Albertas Ulys; Egils Vjaters; Sergey Polyakov; Mindaugas Jievaltas; Murilo Luz; Boris Alekseev; Iris Kuss; Christian Kappeler; Amir Snapir; Toni Sarapohja; Matthew R Smith
Journal:  N Engl J Med       Date:  2019-02-14       Impact factor: 176.079

6.  Discovery of ODM-201, a new-generation androgen receptor inhibitor targeting resistance mechanisms to androgen signaling-directed prostate cancer therapies.

Authors:  Anu-Maarit Moilanen; Reetta Riikonen; Riikka Oksala; Laura Ravanti; Eija Aho; Gerd Wohlfahrt; Pirjo S Nykänen; Olli P Törmäkangas; Jorma J Palvimo; Pekka J Kallio
Journal:  Sci Rep       Date:  2015-07-03       Impact factor: 4.379

7.  Darolutamide is a potent androgen receptor antagonist with strong efficacy in prostate cancer models.

Authors:  Tatsuo Sugawara; Simon J Baumgart; Ekaterina Nevedomskaya; Kristin Reichert; Holger Steuber; Pascale Lejeune; Dominik Mumberg; Bernard Haendler
Journal:  Int J Cancer       Date:  2019-03-23       Impact factor: 7.396

8.  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.

Authors:  Neal Shore; Christian Zurth; Robert Fricke; Hille Gieschen; Kristina Graudenz; Mikko Koskinen; Bart Ploeger; Jonathan Moss; Olaf Prien; Gustavo Borghesi; Oana Petrenciuc; Teuvo L Tammela; Iris Kuss; Frank Verholen; Matthew R Smith; Karim Fizazi
Journal:  Target Oncol       Date:  2019-10       Impact factor: 4.493

9.  Drug-Drug Interaction Potential of Darolutamide: In Vitro and Clinical Studies.

Authors:  Christian Zurth; Mikko Koskinen; Robert Fricke; Olaf Prien; Timo Korjamo; Kristina Graudenz; Karsten Denner; Michaela Bairlein; Clemens-Jeremias von Bühler; Gary Wilkinson; Hille Gieschen
Journal:  Eur J Drug Metab Pharmacokinet       Date:  2019-12       Impact factor: 2.441
  9 in total
  4 in total

Review 1.  Endocrine consequences of treatment with the new androgen receptor axis-targeted agents for advanced prostate cancer.

Authors:  Nikolaos Pyrgidis; Ioannis Vakalopoulos; Petros Sountoulides
Journal:  Hormones (Athens)       Date:  2020-11-02       Impact factor: 2.885

Review 2.  FDA-Approved Small Molecule Compounds as Drugs for Solid Cancers from Early 2011 to the End of 2021.

Authors:  Aleksandra Sochacka-Ćwikła; Marcin Mączyński; Andrzej Regiec
Journal:  Molecules       Date:  2022-03-31       Impact factor: 4.411

Review 3.  Prostate Cancer Brain Metastasis: Review of a Rare Complication with Limited Treatment Options and Poor Prognosis.

Authors:  Kobisha Rajeswaran; Kaitlin Muzio; Juan Briones; Mary Jane Lim-Fat; Chia-Lin Tseng; Martin Smoragiewicz; Jay Detsky; Urban Emmenegger
Journal:  J Clin Med       Date:  2022-07-18       Impact factor: 4.964

Review 4.  Emerging Promise of Computational Techniques in Anti-Cancer Research: At a Glance.

Authors:  Md Mominur Rahman; Md Rezaul Islam; Firoza Rahman; Md Saidur Rahaman; Md Shajib Khan; Sayedul Abrar; Tanmay Kumar Ray; Mohammad Borhan Uddin; Most Sumaiya Khatun Kali; Kamal Dua; Mohammad Amjad Kamal; Dinesh Kumar Chellappan
Journal:  Bioengineering (Basel)       Date:  2022-07-25
  4 in total

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