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Darinaparsin: First Approval

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A Correction to this article was published on 14 November 2022

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Abstract

Darinaparsin (Darvias®), an organoarsenic drug, is a novel mitochondrial-targeted anticancer agent currently being developed by Solasia Pharma K.K for the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL). An intravenous formulation of darinaparsin has been approved for the treatment of relapsed or refractory PTCL in Japan, and preparation for the next stage of the clinical development program for this indication is currently underway in China, the USA and the EU. This article summarizes the milestones in the development of darinaparsin leading to this first approval for relapsed or refractory PTCL.

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References

  1. Fox CP, Ahearne MJ, Ruth P, et al. Guidelines for the management of mature T- and natural killer-cell lymphomas (excluding cutaneous T-cell lymphoma): a British Society for Haematology Guideline. Br J Haematol. 2022;196(3):507–22.

    Article  PubMed  Google Scholar 

  2. Lansigan F, Horwitz SM, Pinter-Brown LC, et al. Outcomes for relapsed and refractory peripheral T-Cell lymphoma patients after front-line therapy from the COMPLETE registry. Acta Haematol. 2020;143(1):40–50.

    Article  PubMed  Google Scholar 

  3. Quintás-Cardama A, Verstovsek S, Freireich E, et al. Chemical and clinical development of darinaparsin, a novel organic arsenic derivative. Anticancer Agents Med Chem. 2008;8(8):904–9.

    Article  PubMed  Google Scholar 

  4. Mann KK, Wallner B, Lossos IS, et al. Darinaparsin: a novel organic arsenical with promising anticancer activity. Expert Opin Investig Drugs. 2009;18(11):1727–34.

    Article  CAS  PubMed  Google Scholar 

  5. Fukuhara N, Kim WS, Yoon DH, et al. Asian multinational phase II study of darinaparsin in patients with relapsed or refractory peripheral T-cell lymphoma [abstract no. 1376]. Blood. 2021;138(Suppl 1):1376.

    Article  Google Scholar 

  6. Solasia Pharma K.K. DARVIAS® Injection 135mg: Japanese prescribing information. 2022

  7. Solasia Pharma K.K. DARVIAS® Injection 135mg (generic name: DARINAPARSIN/development code: SP-02) approved in Japan [media release]. 2022. https://ssl4.eir-parts.net/doc/4597/tdnet/2144731/00.pdf. Accessed 20 Jun 2022

  8. Solasia Pharma K.K. SP-02 overview—pipeline information. https://solasia.co.jp/en/pipeline/sp02.html. Accessed 27 Sep 2022.

  9. Hosein PJ, Craig MD, Tallman MS, et al. A multicenter phase II study of darinaparsin in relapsed or refractory Hodgkin’s and non-Hodgkin’s lymphoma. Am J Hematol. 2012;87(1):111–4.

    Article  CAS  PubMed  Google Scholar 

  10. Berenson JR, Jaganath S, Reece D, et al. ZIO-101 (S-dimethylarsino-glutathione): phase I/II trials in advanced/ progressive multiple myeloma. J Clin Oncol. 2007;25(Suppl. 18):468.

    Google Scholar 

  11. Tsimberidou AM, Camacho LH, Verstovsek S, et al. A phase I clinical trial of darinapars in in patients with refractory solid tumors. Clin Cancer Res. 2009;15(14):4769–76.

    Article  CAS  PubMed  Google Scholar 

  12. Wu J, Henderson C, Feun L, et al. Phase II study of darinaparsin in patients with advanced hepatocellular carcinoma. Invest New Drugs. 2010;28(5):670–6.

    Article  CAS  PubMed  Google Scholar 

  13. Ziopharm Inc. ZIOPHARM starts phase I study of ZIO-101 [media release]. 2005. http://www.ziopharm.com. Accessed 19 May 2005.

  14. Ziopharm Oncology Inc. ZIOPHARM and Solasia Pharma announce license and collaboration agreement for darinaparsin in Asia [media release]. 2011. http://www.ziopharm.com. Accessed 8 Mar 2011.

  15. Ziopharm Oncology Inc. ZIOPHARM Oncology and Solasia Pharma announce global license and collaboration agreement for darinaparsin [media release]. 2014. http://www.ziopharm.com. Accessed 31 Jul 2014.

  16. Solasia Pharma K.K. Announcement concerning signing of license and distribution agreement for SP-02 (darinaparsin injection) in Latin America [media release]. 2018. http://www.solasia.co.jp. Accessed 17 Aug 2018.

  17. Solasia Pharma K.K. Solasia and Nippon Kayaku announce license agreement in Japan for new drug candidate DARINAPARSIN (SP-02) [media release]. 2021. http://solasia.co.jp. Accessed 26 Oct 2021.

  18. Ziopharm Oncology Inc. Ziopharm Oncology highlights operational progress rebrands to Alaunos Therapeutics [media release]. 2022. http://www.alaunos.com. Accessed 26 Jan 2022.

  19. Diaz Z, Mann KK, Marcoux S, et al. A novel arsenical has antitumor activity toward As2O3-resistant and MRP1/ABCC1-overexpressing cell lines. Leukemia. 2008;22(10):1853–63.

    Article  CAS  PubMed  Google Scholar 

  20. Ravi D, Bhalla S, Gartenhaus RB, et al. The novel organic arsenical darinaparsin induces MAPK-mediated and SHP1-dependent cell death in T-cell lymphoma and Hodgkin lymphoma cells and human xenograft models. Clin Cancer Res. 2014;20(23):6023–33.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  21. Matulis SM, Morales AA, Yehiayan L, et al. Darinaparsin induces a unique cellular response and is active in an arsenic trioxide-resistant myeloma cell line. Mol Cancer Ther. 2009;8(5):1197–206.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  22. Khairul I, Wang QQ, Jiang YH, et al. Metabolism, toxicity and anticancer activities of arsenic compounds. Oncotarget. 2017;8:23905–26.

    Article  PubMed  PubMed Central  Google Scholar 

  23. Mason TA, Kolobova E, Liu J, et al. Darinaparsin is a multivalent chemotherapeutic which induces incomplete stress response with disruption of microtubules and Shh signaling. PLoS ONE. 2011;6(11): e27699.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  24. Camacho LH, Hong DS, Verstovek S, et al. Phase-1 trial of ZIO-101, a novel organic arsenic in advanced cancer [abstract no. 413P]. Ann Oncol. 2006;17(Suppl. 9):ix138.

    Google Scholar 

  25. Garnier N, Redstone GG, Dahabieh MS, et al. The novel arsenical darinaparsin is transported by cystine importing systems. Mol Pharmacol. 2014;85(4):576–85.

    Article  PubMed  Google Scholar 

  26. Ohno N, Tani A, Chen ZS, et al. Prognostic significance of multidrug resistance protein in adult T-cell leukemia. Clin Cancer Res. 2001;7:3120–6.

    CAS  PubMed  Google Scholar 

  27. Ogura M, Kim WS, Uchida T, et al. Phase I studies of darinaparsin in patients with relapsed or refractory peripheral T-cell lymphoma: a pooled analysis of two phase I studies conducted in Japan and Korea. Jpn J Clin Oncol. 2021;51(2):218–27.

    Article  PubMed  Google Scholar 

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    James E. Frampton

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  1. James E. Frampton
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Correspondence to James E. Frampton.

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

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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. James E. Frampton is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

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This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch and beyond.

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Frampton, J.E. Darinaparsin: First Approval. Drugs 82, 1603–1609 (2022). https://doi.org/10.1007/s40265-022-01795-z

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