nach oben

Drugs

Erschienen in:

01.06.2019 | AdisInsight Report

Erdafitinib: First Global Approval

verfasst von: Anthony Markham

Erschienen in: Drugs | Ausgabe 9/2019

Einloggen, um Zugang zu erhalten

Abstract

Erdafitinib (Balversa™, Janssen Pharmaceutical Companies) is a pan-fibroblast growth factor receptor (FGFR) inhibitor that was recently approved in the USA for the treatment of locally advanced or metastatic FGFR3 or FGFR2 urothelial carcinoma. The drug is also being investigated as a treatment for other cancers including cholangiocarcinoma, liver cancer, non-small cell lung cancer, prostate cancer, lymphoma and oesophageal cancer. This article summarizes the milestones in the development of erdafitinib leading to this first approval for the treatment of urothelial carcinoma.

Janssen Pharmaceuticals. BALVERSA^TM (erdafitinib): US prescribing information. 2019. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212018s000lbl.pdf. Accessed 7 May 2019.

Karkera JD, Cardona GM, Bell K, et al. Oncogenic characterization and pharmacologic sensitivity of activating fibroblast growth factor receptor (FGFR) genetic alterations to the selective FGFR inhibitor erdafitinib. Mol Cancer Ther. 2017;16(8):1717–26.CrossRefPubMed

Tabernero J, Bahleda R, Dienstmann R, et al. Phase I dose-escalation study of JNJ-42756493, an oral pan-fibroblast growth factor receptor inhibitor, in patients with advanced solid tumors. J Clin Oncol. 2015;33(30):3401–8.CrossRefPubMed

FDA. FDA approves first targeted therapy for metastatic bladder cancer [media release]. 12 Apr 2019. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635906.htm.

Astex Therapeutics. Astex announces new drug discovery alliance with Janssen Pharmaceutica N.V [media release]. 9 Jun 2008. http://www.astex-therapeutics.com.

Astex Therapeutics. Astex announces new drug discovery collaboration with University of Newcastle upon Tyne and Cancer Research Technology Limited [media release]. 13 Mar 2006. http://www.astex-therapeutics.com.

Astex Pharmaceuticals Inc. SuperGen and Astex Therapeutics enter definitive merger agreement [media release]. 6 Apr 2011. https://astx.com/.

Otsuka Holdings Co Ltd. Otsuka Pharmaceutical completes acquisition of Astex Pharmaceuticals [media release]. 11 Oct 2013. http://www.otsuka.co.jp.

Perera TPS, Jovcheva E, Mevellec L, et al. Discovery and pharmacological characterization of JNJ-42756493 (erdafitinib), a functionally selective small-molecule FGFR family inhibitor. Mol Cancer Ther. 2017;16(6):1010–20.CrossRefPubMed

10.

Nishina T, Takahashi S, Iwasawa R, et al. Safety, pharmacokinetic, and pharmacodynamics of erdafitinib, a pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor, in patients with advanced or refractory solid tumors. Invest New Drugs. 2018;36(3):424–34.CrossRefPubMed

11.

Tabernero J, Infante JR, Mita A, et al. Pharmacokinetics (PK) of the pan-FGFR inhibitor erdafitinib in urothelial carcinoma [abstract no. 789P]. Ann Oncol. 2016;27(Supplement 6).

12.

Siefker-Radtke AO, Necchi A, Park SH, et al. First results from the primary analysis population of the phase 2 study of erdafitinib (ERDA; JNJ-42756493) in patients (pts) with metastatic or unresectable urothelial carcinoma (mUC) and FGFR alterations (FGFRalt) [abstract no. 4503]. J Clin Oncol. 2018;36(15 Supplement):4503.

13.

Chen YY, Park JO, Su WC, et al. Preliminary results of a ph2a study to evaluate the clinical efficacy and safety of erdafitinib in Asian patients with biomarker-selected advanced cholangiocarcinoma (CCA) [abstract no. 624PD]. Ann Oncol. 2018;29(Supplement 8):viii209.

14.

Loriot Y, Necchi A, Park SH, et al. Erdafitinib compared with vinflunine or docetaxel or pembrolizumab in patients (pts) with metastatic or surgically unresectable (M/UR) urothelial carcinoma (UC) and selected FGFR gene alterations (FGFRalt): the phase III THOR study [abstract no. 920TiP]. Ann Oncol. 2018;29(Supplement 8):viii327–viii8.

15.

Nogova L, Malchers F, Zadoyan G, et al. FIND trial: a phase II study to evaluate the efficacy of the FGFR-inhibitor erdafitinib in FGFR-mutated and -translocated squamous NSCLC [abstract no. P1.01-72]. J Thorac Oncol. 2018;13 (10 Suppl.):S490.

Titel: Erdafitinib: First Global Approval
verfasst von: Anthony Markham
Publikationsdatum: 01.06.2019
Verlag: Springer International Publishing
Erschienen in: Drugs / Ausgabe 9/2019
Print ISSN: 0012-6667
Elektronische ISSN: 1179-1950
DOI: https://doi.org/10.1007/s40265-019-01142-9

Live-Webinar "Urologie und Sexualmedizin in der Praxis"

Springer Medizin

Erdafitinib: First Global Approval

Abstract

Live-Webinar "Urologie und Sexualmedizin in der Praxis"

Springer Medizin

Abstract

Bitte loggen Sie sich ein, um Zugang zu diesem Inhalt zu erhalten

Weitere Artikel der Ausgabe 9/2019

Siponimod: First Global Approval

Cannabinoids: Current and Future Options to Treat Chronic and Chemotherapy-Induced Neuropathic Pain

Tiotropium/Olodaterol: A Review in COPD

Mechanism of Action and Clinical Attributes of Auryxia® (Ferric Citrate)

Sotagliflozin: First Global Approval

Fibrosis in Chronic Liver Disease: An Update on Diagnostic and Treatment Modalities