FDA Approves Besremi for Treatment of Polycythemia Vera

Results of studies show about 61% of individuals with PV experienced a complete hematological response.

The FDA has approved ropeginterferon alfa-2b-njft (Besremi, PharmaEssentia Corporation) for the treatment of individuals with polycythemia vera (PV), according to a statement from the company.

“The FDA approval of Besremi for people with polycythemia vera represents the next step in advancing patient care, as 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,” Srdan Verstovsek, MD, PhD, director of the Hanns A. Pielenz Clinical Research Center for Myeloproliferative Neoplasms at the department of leukemia at the University of Texas MD Anderson Cancer Center, said in the statement.

Ropeginterferon is an innovative monopegylated, long-acting interferon that effects the cellular effects of PV in the bone marrow. It was approved with the risk of serious disorders, including aggravation of neuropsychiatric autoimmune, infection, and ischemic disorders.

The results of various studies show that after 7.5 years of treatment with ropeginterferon about 61% of individuals with PV experienced a complete hematological response. About 80% of individuals achieved a hematological response.

The safety profile included adverse events, such as arthralgia, fatigue, influenza-like illness, musculoskeletal pain, nasopharyngitis, and pruritis.

The approval was based on the safety from the PEGINVERA and PROUD/CONTINUATION-PV studies and efficacy data from the PEGINVERA clinical study.

PV is a chronic and rare blood cancer caused by a mutation in stem cells in the bone marrow and results in overproducing blood cells.

Reference

US FDA approves Besremi (ropeginterferon alfa-2b-njft) as the only interferon for adults with polycythemia vera. BusinessWire. News release. November 12, 2021. Accessed November 16, 2021. https://www.businesswire.com/news/home/20211112005909/en