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NCCN Recommends Ropeginterferon Alfa-2b in Clinical Practice Guidelines Update

March 2022


The National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology has been updated to include ropeginterferon alfa-2b (Besremi) as a recommended treatment option for adult patients with polycythemia vera. Polycythemia vera is a blood disorder characterized by the overproduction of red blood cells. The inclusion of ropeginterferon alfa-2b in the guidelines is seen as a shift toward more proactive treatment earlier in the disease journey.


The decision to recommend ropeginterferon alfa-2b is based on findings from clinical trials, including PEGINVERA, PROUD-PV, and CONTINUATION-PV. In the PEGINVERA trial, 61% of patients achieved a complete hematological response after 7.5 years of treatment with ropeginterferon alfa-2b. Most patients (80%) developed a hematological response with the agent, including normal spleen size and reduced thrombosis.


Common adverse effects of ropeginterferon alfa-2b reported in the trials included influenza-like illness, arthralgia, fatigue, pruritis, nasopharyngitis, and musculoskeletal pain. Serious adverse reactions were urinary tract infection, transient ischemic attack, and depression.


The PROUD-PV and CONTINUATION-PV trials compared ropeginterferon alfa-2b with hydroxyurea, a commonly used treatment for polycythemia vera. The results showed that ropeginterferon alfa-2b was non-inferior to hydroxyurea in achieving a complete hematological response with normal spleen size at 1 year. Furthermore, improved disease burden was observed in a higher percentage of patients treated with ropeginterferon alfa-2b compared to hydroxyurea at 36 months.


Ropeginterferon alfa-2b is approved with a boxed warning for the risk of aggravating neuropsychiatric, autoimmune, ischemic, and infectious disorders. The inclusion of ropeginterferon alfa-2b in the NCCN guidelines shortly after its approval highlights its potential in the care of polycythemia vera patients.


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References


  1. NCCN clinical practice guidelines in oncology update recommends besremi (ropeginterferon alfa-2b-njft) for the treatment of polycythemia vera. News release. PharmaEssentia. March 2, 2022. Accessed March 2, 2022. https://bit.ly/3HwMNr7

  2. Besremi. Prescribing information. PharmaEssentia; 2021. Accessed March 2, 2022. https://bit.ly/3IFyj9J

  3. Gisslinger H, Klade C, Georgiev P, et al. Ropeginterferon alfa-2b versus standard therapy for polycythaemia vera (PROUD-PV and CONTINUATION-PV): a randomised, non-inferiority, phase 3 trial and its extension study. Lancet Haematol. 2020;7(3):e196-e208. doi:10.1016/S2352-3026(19)30236-4

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