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FOLOTYN® (Pralatrexate Injection)

About FOLOTYN® (Pralatrexate Injection)

FOLOTYN® (Pralatrexate) is a 10-deazaaminopterin derivative and acts an inhibitor of DHFR (dihydrofolate reductase) indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).


Compared with methotrexate, pralatrexate could be more effectively internalized into tumor cells and more toxic than normal cells. Clinical studies have demonstrated that pralatrexate has significant activity against PTCL and could be a promising treatment option for Chinese patients with relapsed or refractory PTCL.


Pralatrexate was approved for medical use in the United States in September 2009, as the first treatment for PTCL. Then it was approved in Japan and China in 2017 and 2020, respectively.

About Peripheral T-cell Lymphoma (PTCL)

Peripheral T cell lymphoma (PTCL) is comprised of a heterogeneous group of lymphomas which account for 5-15% of non-Hodgkin lymphomas (NHL); with an incidence of 0.5–2 per 100,000 in the western countries. In Asia, approximately 15% to 20% of lymphomas are categorized as PTCL2,3. PTCL is often aggressive and is classically described as peripheral (systemic) and cutaneous forms which develop from T-cells and natural killer (NK) cells1. As per the latest World Health Organization (WHO) classification there are over 29 different subcategories of PTCL4. Anthracycline-based chemotherapy regimens are the most commonly used first-line treatment regimens.


  1.Vose J, Armitage J, Weisenburger D, International T-Cell Lymphoma Project. International peripheral T-cell and natural killer/T-cell lymphoma study: pathology findings and clinical outcomes. J Clin Oncol. 2008; 26(25): 4124-4130.

  2.Muto R, Miyoshi H, Sato K, Furuta T, Muta H, Kawamoto K, et al. Epidemiology and Secular Trends of Malignant Lymphoma in Japan: Analysis of 9426 Cases According to the World Health Organization Classification. Cancer Med (2018) 7(11):5843–58. doi:  10.1002/cam4.1805 

  3.Kim JM, Ko YH, Lee SS, Huh J, Kang CS, Kim CW, et al. WHO Classification of Malignant Lymphomas in Korea: Report of the Third Nationwide Study. J Pathol Transl Med (2011) 45(3):254–60. doi:  10.4132/KoreanJPathol.2011.45.3.254

  4.Swerdlow SH, et al. WHO classification of tumours of haematopoietic and lymphoid tissues. 4th ed. International agency for research on Cancer (IARC); 2017. IARC WHO Classification of Tumours, Volume 2.


Please see FOLOTYN® product and safety information.