BURLINGTON, Mass. — PharmaEssentia USA Corporation announced that the National Comprehensive Cancer Network has updated its Clinical Practice Guidelines in Oncology to include ropeginterferon alfa-2b-njft (BESREMi) as a Category 1 preferred treatment option for patients with high-risk essential thrombocythemia who have had an inadequate response to, or lost response to, existing therapies.
According to the company, the updated NCCN guidelines recognize ropeginterferon alfa-2b-njft as a recommended regimen for this patient population based on high-level evidence and uniform consensus among NCCN experts. Category 1 recommendations indicate that an intervention is supported by strong clinical data and broad agreement regarding its appropriateness.
The use of ropeginterferon alfa-2b-njft for essential thrombocythemia remains investigational and is currently under review by the U.S. Food and Drug Administration.
“Inclusion of ropeginterferon alfa-2b-njft as a Category 1 preferred regimen in the NCCN Guidelines represents a significant milestone for patients with essential thrombocythemia and for the physicians who treat them,” said Ko-Chung Lin, Ph.D., Founder and Chief Executive Officer of PharmaEssentia. “This update recognizes the strength of the clinical evidence and reinforces its role as an important potential therapeutic option for high-risk patients with limited treatment alternatives. The FDA’s review of our supplemental Biologics License Application (sBLA) to expand the ropeginteron alfa-2b-njft label to include patients with ET is ongoing, and we are prepared to expand commercialization into this important patient population, pending approval.”
The NCCN is a not-for-profit alliance of leading cancer centers in the United States. Its Clinical Practice Guidelines in Oncology are widely used by oncologists and hematologists and are frequently referenced in treatment decision-making, as well as in coverage and reimbursement determinations by public and private payers.
PharmaEssentia USA Corporation is a subsidiary of PharmaEssentia Corporation, a global biopharmaceutical company focused on developing biologics for hematology and oncology indications. The company is the developer and owner of BESREMi, which is currently approved by the FDA for the treatment of adults with polycythemia vera. PharmaEssentia has submitted a supplemental Biologics License Application seeking to expand the indication to include essential thrombocythemia.
Essential thrombocythemia is a rare blood disorder classified as a myeloproliferative neoplasm. It is characterized by the overproduction of platelets in the bone marrow and is associated with an increased risk of blood clots, abnormal bleeding, and splenomegaly. The condition is often linked to genetic mutations, including mutations in the JAK2 gene.
BESREMi has received orphan drug designation in the United States for the treatment of polycythemia vera and has been approved in more than 40 countries worldwide, including approvals from U.S., European, and Japanese regulatory authorities.
