On November 18, 2021 Onco360, the nation’s leading independent Specialty Pharmacy, reported that has been selected by PharmaEssentia to be a specialty pharmacy partner for BESREMi (ropeginterferon alfa-2b-njft) which is now approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with polycythemia vera (Press release, Onco360, NOV 18, 2021, View Source [SID1234595811]).

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"Onco360 is honored to become a specialty pharmacy provider for BESREMi patients," said Benito Fernandez, Chief Commercial Officer, Onco360. "We are committed to supporting the highly specialized needs of polycythemia vera patients and their physicians across the United States."

According to the National Comprehensive Cancer Network (NCCN) Guidelines for the Treatment of Myeloproliferative Neoplasms, polycythemia vera is one of several disorders of the hematopoietic system under a broader classification known as Philadelphia chromosome-negative myeloproliferative neoplasms (MPNs). The prevalence of polycythemia in the United States is approximately 148,000 cases.1 Polycythemia vera results from abnormal red blood cell proliferation due to genetic mutations involving the Janus Kinase 2 (JAK2) gene. Due to over-production of red blood cells, patients with polycythemia vera have blood which is thicker than normal, potentially resulting in increased risks for thrombosis and reduction in blood flow.2 The average age at initial polycythemia vera diagnosis is 60-65 years old. The median overall survival for patients diagnosed with polycythemia vera is approximately 20 years.3

BESREMi is manufactured by PharmaEssentia, a growing biopharmaceutical innovator based in Taiwan. The FDA’s approval of BESREMi is based upon the results of the PEGINVERA study, a prospective, multicenter, single-arm trial of 7.5 years duration. This study demonstrated that BESREMi administration resulted in 61% of patients achieving a complete hematological response (CHR) during the treatment period defined as hematocrit <45% and no phlebotomy in the preceding 2 months, platelets < 400 x 109/L and leukocytes < 10 x 109/L, normal spleen size assessed by ultrasound and absence of thromboembolic events.4

BESREMi was approved with a boxed warning for risk of serious disorders including aggravation of neuropsychiatric, autoimmune, ischemic and infectious disorders. Please see accompanying full Prescribing Information, including Boxed Warning. For more information, visit www.BESREMi.com.