, Volume 79, Issue 9, pp 1017–1021 | Cite as

Erdafitinib: First Global Approval

  • Anthony MarkhamEmail author
AdisInsight Report


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.


Compliance with Ethical Standards


The preparation of this review was not supported by any external funding.

Conflicts of interest

During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. A. Markham, a contracted employee of Adis International Ltd/Springer Nature, is responsible for the article content and declares no relevant conflicts of interest.


  1. 1.
    Janssen Pharmaceuticals. BALVERSATM (erdafitinib): US prescribing information. 2019. Accessed 7 May 2019.
  2. 2.
    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.CrossRefGoogle Scholar
  3. 3.
    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.CrossRefGoogle Scholar
  4. 4.
    FDA. FDA approves first targeted therapy for metastatic bladder cancer [media release]. 12 Apr 2019.
  5. 5.
    Astex Therapeutics. Astex announces new drug discovery alliance with Janssen Pharmaceutica N.V [media release]. 9 Jun 2008.
  6. 6.
    Astex Therapeutics. Astex announces new drug discovery collaboration with University of Newcastle upon Tyne and Cancer Research Technology Limited [media release]. 13 Mar 2006.
  7. 7.
    Astex Pharmaceuticals Inc. SuperGen and Astex Therapeutics enter definitive merger agreement [media release]. 6 Apr 2011.
  8. 8.
    Otsuka Holdings Co Ltd. Otsuka Pharmaceutical completes acquisition of Astex Pharmaceuticals [media release]. 11 Oct 2013.
  9. 9.
    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.CrossRefGoogle Scholar
  10. 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.CrossRefGoogle Scholar
  11. 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).Google Scholar
  12. 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.Google Scholar
  13. 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.Google Scholar
  14. 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.Google Scholar
  15. 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.Google Scholar

Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  1. 1.Springer NatureAucklandNew Zealand

Personalised recommendations