Beslemi Receives Preferred Treatment Designation for Polycythemia Vera

Bethlemi (lopeginterferon alfa-2b-njft) – an adult treatment for myeloproliferative neoplasm polycythemia vera (PV) – is currently available for both high-risk and low-risk PV patients, regardless of prior treatment. It has become the preferred treatment option. The National Comprehensive Cancer Network’s clinical practice guidelines in oncology have been updated, according to a news release from drug development company PharmaEssentia USA.

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

“Importantly, the updates to the NCCN Guidelines include moving Beslemi to Priority status and reinforcing to treating physicians and patients that Beslemi is recommended for aggressive treatment of PV due to Beslemi’s broad utility. “It’s what we’re doing,” said John Mascarenhas, Ph.D., professor of Medicine, Hematology, and Medical Oncology at the NCCN Guidelines. Icahn School of Medicine in Mount Sinai, New York, said in a news release.

PharmaEssentia announced that as of the May 19 NCCN guideline update, Bethlemi is the preferred treatment and is considered both a Category 2A treatment, which is the NCCN It means that there is a unified consensus.” It is currently intended to be administered every 2 weeks or every 4 weeks after at least 1 year of hematological stability.

“The recent treatment guideline update by NCCN represents community recognition of the value of Bethlemi as a treatment option for all adults with PV, regardless of prior treatment,” Pharma Escenta Clinical Director of Development and Medical Affairs, Dr. Raymond Urbanski said. , stated in the press release. “We continue to study Bethlemi not only in PV, but also in other myeloproliferative neoplasms (MPNs) and haematological malignancies because of its deep and lasting control of disease beyond symptoms.”

The first patient was recently administered in a 24-week Phase 3B clinical trial evaluating an accelerated dose of Beslemi. It started at 250 μg, increased to 350 μg at 2 weeks, and targeted 500 μg at 4 weeks, as opposed to the current dose. Doses of 50 or 100 mcg are approved. The study is scheduled to be completed in December 2025.

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