The FDA approved subcutaneous ropeginterferon alfa-2b-njft (Besremi) to treat adult patients with polycythemia vera, a rare blood cancer.
Polycythemia vera—which affects approximately 6,200 individuals in the U.S. every year, according to the FDA—causes overproduction of red blood cells, leading to thickening of the blood, slower blood circulation, and an increased risk of blood clots.
Traditional treatment for polycythemia vera involves phlebotomies and medications intended to reduce the number of blood cells; ropeginterferon alfa-2b-njft fits into the latter category. However, unlike other treatments for the disease, this is the first one approved that patients can use regardless of treatment history, as well as the first interferon therapy specifically indicated for polycythemia vera.
“The effectiveness and safety of [ropeginterferon alfa-2b-njft] were evaluated in a multicenter, single-arm trial that lasted 7.5 years,” the FDA explained. “In this trial, 51 adults with polycythemia vera received [ropeginterferon alfa-2b-njft] for an average of about five years. [Ropeginterferon alfa-2b-njft]’s effectiveness was assessed by looking at how many patients achieved complete hematological response, which meant that patients had a red blood cell volume of less than 45% without a recent phlebotomy, normal white cell counts and platelet counts, a normal spleen size, and no blood clots. Overall, 61% of patients had a complete hematological response.”
The agency warned that this interferon treatment can cause liver enzyme elevations, leukopenia, thrombocytopenia, joint pain, fatigue, itching, upper airway infection, muscle pain, and flu-like illness; side effects may also include urinary tract infection, depression, and transient ischemic attacks.
“Interferon alfa products like [ropeginterferon alfa-2b-njft] may cause or worsen neuropsychiatric, autoimmune, ischemic (not enough blood flow to a part of the body) and infectious diseases, which could lead to life-threatening or fatal complications,” the FDA added. The drug is contraindicated for patients who are allergic to the drug, individuals with a severe psychiatric disorder or a history of the same, immunosuppressed transplant patients, certain patients with autoimmune disease or a history of the same, and patients with liver disease. Due to risk of fetal harm, individuals who can become pregnant should be tested for pregnancy prior to treatment initiation.
Ropeginterferon alfa-2b-njft is manufactured by PharmaEssentia Corporation.
John McKenna, Associate Editor, BreakingMED™
Cat ID: 118
Topic ID: 78,118,730,118,192,725,925
