Besremi is included as an option to treat the rare blood disorder polycythemia vera regardless of treatment history and for use in both low- and high-risk settings.
The National Comprehensive Cancer Network (NCCN) has updated its Clinical Practice Guidelines in Oncology to include Besremi (ropeginterferon alfa-2b-njft) as a recommended option for the treatment of adults with polycythemia vera (PV). Besremi, which was developed by PharmaEssentia, is a long-acting interferon.
The FDA approved Besremi in November 2021 to treat adults with polycythemia vera, a cancer originating in the bone marrow that results in a chronic increase of red blood cells, white blood cells, and platelets. PV may result in cardiovascular complications such as thrombosis and embolism, and often transforms to secondary myelofibrosis or leukemia.
“Importantly, the NCCN Guidelines update includes mention of Besremi in multiple settings, and in particular, as the only systemic option for low-risk patients with PV, which signals a shift toward more proactive treatment earlier in the disease journey,” Ruben Mesa, M.D., executive director of the UT Health San Antonio MD Anderson Cancer Center, said in a press release. “Now, treating physicians can leverage these expert guidelines to gain greater familiarity with Besremi in the real-world setting and understand its broad utility for patient care in a variety of treatment settings.”
Besremi is the first FDA-approved medication for polycythemia vera that patients can take regardless of their treatment history, and the first interferon therapy specifically approved for polycythemia vera. Besremi is a long-acting drug that patients take by injection under the skin once every two weeks. PharmaEssentia has chosen Onco360 to be a specialty pharmacy partner for Besremi.
Besremi has orphan drug designation for treatment of polycythemia vera in the United States. The product was also approved by the European Medicines Agency (EMA) in 2019.
PharmaEssentia is continuing research of the long-acting interferon. It is under evaluation for the treatment of patients with essential thrombocythemia, which is the overproduction of platelets in the blood that results from a genetic mutation; data indicates a JAK2 gene mutation is present in about half of diagnosed patients. PharmaEssentia continues to enroll participants in the trial at sites throughout the United States, Asia, and Canada.