FDA Approves Besremi for Polycythemia Vera

The Food and Drug Administration granted approval to Besremi for the treatment of adults with polycythemia vera.

The Food and Drug Administration (FDA) approved Besremi (ropeginterferon alfa-2b-njft) to treat adults with polycythemia vera, a rare type of blood cancer in which the bone marrow produces too many red blood cells due to a mutation in the stem cells.

“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,” said Dr. Srdan Verstovsek, Director of the Hanns A. Pielenz Clinical Research Center for Myeloproliferative Neoplasms at the University of Texas MD Anderson Cancer Center in Houston, in a news release.

Besremi is a long-acting interferon – or group of signaling proteins released in response to a virus – and is administered once every two weeks or longer to meet a patient’s individual needs. If a patient reaches a stable complete hematologic response after one year on treatment, they can then receive Besremi every four weeks.

“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,” Verstovsek said.

The FDA based its approval on data from the PEGINVERA and PROUD/ CONTINUATION-PV studies and PEGINVERA clinical study program. In the study, 61% of patients who were treated with Besremi for 7.5 years had a complete hematological response. Additionally, 80% of patients achieved a hematological response.

The most common side effects experienced by patients treated with Besremi were influenza-like illness, arthralgia (joint stiffness), fatigue, pruritis (itchy skin), nasopharyngitis (common cold) and musculoskeletal pain.

“The reality of living with a rare and chronic cancer like polycythemia vera is that it is often underrecognized and the limited treatments available cannot properly address the disease beyond the symptoms,” said Ann Brazeau, CEO of MPN Advocacy and Education International, in the release. “Our community welcomes the FDA approval of a new treatment that has the potential to deliver what has been unavailable for so many patients hoping for a better outlook.”

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