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01.11.2019 | AdisInsight Report

Darolutamide: First Approval

verfasst von: Anthony Markham, Sean Duggan

Erschienen in: Drugs | Ausgabe 16/2019

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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.

Fizazi K, Smith MR, Tombal B. Clinical development of darolutamide: a novel androgen receptor antagonist for the treatment of prostate cancer. Clin Genitourin Cancer. 2018;16(5):332–40.CrossRef

US Food & Drug Administration. FDA approves darolutamide for non-metastatic castration-resistant prostate cancer [media release]. 1 Aug 2019. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-darolutamide-non-metastatic-castration-resistant-prostate-cancer.

Bayer. Bayer submits European marketing authorization application for darolutamide [media release]. 8 Mar 2019. http://www.bayer.com.

Orion. Darolutamide submitted for marketing authorization in Japan [media release]. 5 Mar 2019. http://www.orion.fi.

Bayer HealthCare Pharmaceuticals Inc. Nubeqa™ (darolutamide): US prescribing information. 2019. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212099Orig1s000lbl.pdf. Accessed 19 Aug 2019.

Orion. Orion group interim report January-September 2013 [media release]. 22 Oct 2013. http://www.orion.fi.

Bayer. Bayer and Orion Corporation to develop and commercialize novel prostate cancer treatment [media release]. 2 Jun 2014. http://www.bayerpharma.com.

Bayer. Bayer and Orion expand clinical development program for BAY-1841788 (ODM-201) in prostate cancer [media release]. 3 Jun 2016. http://www.bayer.us.

Sugawara T, Baumgart SJ, Nevedomskaya E, et al. Darolutamide is a potent androgen receptor antagonist with strong efficacy in prostate cancer models. Int J Cancer. 2019;145(5):1382–94.PubMedPubMedCentral

10.

Moilanen AM, Riikonen R, Oksala R, et al. Discovery of ODM-201, a new-generation androgen receptor inhibitor targeting resistance mechanisms to androgen signaling-directed prostate cancer therapies. Sci Rep. 2015;5:12007.CrossRef

11.

Zurth C, Koskinen M, Fricke R, et al. Drug–drug interaction potential of darolutamide: in vitro and clinical studies. Eur J Drug Metab Pharmacokinet. 2019. https://doi.org/10.1007/s13318-019-00577-5.CrossRefPubMedPubMedCentral

12.

Shore N, Zurth C, Fricke R, et al. 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. Target Oncol. 2019. https://doi.org/10.1007/s11523-019-00674-0.CrossRefPubMedPubMedCentral

13.

Fizazi K, Massard C, Bono P, et al. 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. Lancet Oncol. 2014;15(9):975–85.CrossRef

14.

Massard C, Penttinen HM, Vjaters E, et al. Pharmacokinetics, antitumor activity, and safety of ODM-201 in patients with chemotherapy-naive metastatic castration-resistant prostate cancer: an open-label phase 1 study. Eur Urol. 2016;69(5):834–40.CrossRef

15.

Fizazi K, Shore N, Tammela TL, et al. Darolutamide in nonmetastatic, castration-resistant prostate cancer. N Engl J Med. 2019;380(13):1235–46.CrossRef

16.

Shore ND, Tammela TL, Massard C, et al. 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. Eur Urol Focus. 2018;4(4):547–53.CrossRef

17.

Smith MR, Saad F, Hussain M, et al. ARASENS: a phase 3 trial of darolutamide in combination with docetaxel for men with metastatic hormone-sensitive prostate cancer (mHSPC) [abstract no. TPS383]. J Clin Oncol. 2018;36(6 Suppl).CrossRef

18.

Gillessen S, Hayoz S, Fuhrer AC, et al. A phase 2 trial of ODM-201 maintenance therapy in patients with metastatic castration resistant prostate cancer (mCRPC) previously treated with a AR targeting agent and nonprogressive on a second line taxane (SAKK 08/16) [abstract no. TPS393]. J Clin Oncol. 2018;36(6 Suppl).

19.

Tombal BF, Gillessen S, Loriot Y, et al. Intergroup study EORTC-1532-gucg: a phase 2 randomized open-label study of oral darolutamide (ODM-201) vs. androgen deprivation therapy (ADT) with LHRH agonists or antagonist in men with hormone naive prostate cancer (PCa) [abstract no. TPS406]. J Clin Oncol. 2018;36(6 Suppl).CrossRef

20.

Alliance for Clinical Trials in Oncology. ARACOG: Phase II study of androgen receptor and cognitive function in patients treated with darolutamide or enzalutamide. 2019. https://www.allianceforclinicaltrialsinoncology.org. Accessed 30 Sep 2019.

21.

Us TOO International. August 2019 Hot Sheet. 2019. https://www.ustoo.org/Read-the-HotSheet-Newsletter. Accessed 30 Sept 2019.

Titel: Darolutamide: First Approval
verfasst von: Anthony Markham
Sean Duggan
Publikationsdatum: 01.11.2019
Verlag: Springer International Publishing
Erschienen in: Drugs / Ausgabe 16/2019
Print ISSN: 0012-6667
Elektronische ISSN: 1179-1950
DOI: https://doi.org/10.1007/s40265-019-01212-y

Live-Webinar "Urologie und Sexualmedizin in der Praxis"

Springer Medizin

Darolutamide: First Approval

Abstract

Live-Webinar "Urologie und Sexualmedizin in der Praxis"

Springer Medizin

Abstract

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