Besremi Designated as Preferred Treatment for Polycythemia Vera

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Two years after receiving FDA approval, Besremi is a preferred treatment option in the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology.

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Besremi (ropeginterferon alfa-2b-njft) is now a preferred therapeutic option for patients with both high- and low-risk polycythemia vera, according to the National Comprehensive Cancer Network.

Besremi (ropeginterferon alfa-2b-njft) — a treatment for adults with the myeloproliferative neoplasm polycythemia vera (PV) — is now a preferred therapeutic option for patients with both high- and low-risk PV, regardless of their treatment history, according to the updated National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology, according to a news release from drug developer, PharmaEssentia USA.

The U.S. Food and Drug Administration (FDA) approved Besremi in 2021, and last year the NCCN Guidelines were revised to include it as a recommended treatment for adults with PV, a type of blood cancer where the bone marrow makes too many red blood cells.

“Importantly, the NCCN Guidelines update includes moving Besremi to preferred status, reinforcing to treating physicians and patients that with its broad utility, Besremi is recommended for proactively treating PV,” Dr. John Mascarenhas, professor of medicine, hematology and medical oncology at the Icahn School of Medicine at Mount Sinai in New York, said in the news release.

Besremi, as of the May 19 NCCN Guidelines update, is considered both a preferred treatment and a category 2A therapy, meaning “there is uniform NCCN consensus that the intervention is appropriate,” according to the PharmaEssentia announcement. It is currently intended to be administered every two weeks, or every four weeks after at least a year of hematological stability.

“This recent update to treatment guidelines by NCCN represents the community’s recognition of the value of Besremi as a therapeutic option for all adults with PV, regardless of their treatment history,” said Dr. Raymond Urbanski, head of clinical development and medical affairs for PharmaEssenta, in the press release. “Given its deep, durable control over the disease beyond the symptoms, we’re continuing to study Besremi in PV, as well as other myeloproliferative neoplasms (MPNs) and hematologic malignancies.”

The first patient was recently dosed in a 24-week phase 3B clinical trial evaluating an accelerated dose of Besremi — starting at 250 mcg then increasing to 350 mcg at week two, with a goal of 500 mcg at week four, as opposed to the currently approved dosing of 50 or 100 mcg. The study is expected to be completed in December 2025.

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