Besremi (ropeginterferon alfa-2b-njft) is the first interferon approved specifically as a treatment for polycythemia vera.
The National Comprehensive Cancer Network (NCCN) has updated its clinical practice guidelines to include the first interferon specifically approved for treating polycythemia vera, a rare disorder but one of the most common types of myeloproliferative neoplasms.
The FDA approved Besremi (ropeginterferon alfa-2b-njft), a long-acting interferon, in November 2021 as a treatment for polycythemia vera in adults. The disease results in overabundance of red blood cells and is treated therapeutic phlebotomy. But in some patients, especially those at higher risk for complications from polycythemia vera, patients, are prescribed cytoreductive agents such as hydroxyurea. The approval of Besremi gives physicians and patients another cytoreductive therapy option.
“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 issued by PharmaEssentia, the Taiwanese company that is making and marketing Beremi.
The FDA news release about Besremi’s approval describes it as 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.
Like other interferon alfa products, Besremi has a boxed warning that it can cause or aggravate neuropsychiatric, autoimmune, ischemic or infectious disorder that can be life threatening.
Besremi is administered as a subcutaneous injection every two weeks. The dose is halved if the patient is also being treated with hydroxurea.