FDA approves Besremi for polycythemia vera
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The FDA approved ropeginterferon alfa-2b-njft for the treatment of adults with polycythemia vera.
Ropeginterferon alfa-2b-njft (Besremi, PharmaEssentia) is a monopegylated, long-acting interferon.
The approval includes a boxed warning about risk for serious disorders, including aggravation of neuropsychiatric, autoimmune, ischemic and infections disorders.
“The FDA approval of Besremi for people with polycythemia vera represents the next step in advancing patient care,” Srdan Verstovsek, MD, PhD, director of Hanns A. Pielenz Clinical Research Center for Myeloproliferative Neoplasms at The University of Texas MD Anderson Cancer Center and a HemOnc Today Editorial Board member, said in a PharmaEssentia-issued press release. “It provides a critical addition to managing not only symptom burden and near-term complications, but also treating the cancer early, which may help reduce the risk of disease progression over time. With the availability of an FDA-approved, next-generation interferon for this indication, it’s time that we focus on preserving the long-term health of patients with polycythemia vera.”
The FDA based approval on efficacy results from the PEGINVERA clinical study program. After 7.5 years of treatment with ropeginterferon alfa-2b-njft, 80% of patients with polycythemia vera achieved hematologic response and 61% achieved complete hematological response.
Pooled safety data from multiple studies showed the most common adverse events among patients treated with ropeginterferon alfa-2b-njft included influenza-like illness, arthralgia, fatigue, pruritus, nasopharyngitis and musculoskeletal pain. Serious adverse events that occurred among more than 4% of study participants included urinary tract infection, transient ischemic attack and depression.
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