Ropeginterferon Alfa Gains NCCN Backing in Essential Thrombycythemia
In a significant shift for the treatment landscape of essential thrombocythemia (ET), the US National Comprehensive Cancer Network (NCCN) has designated ropeginterferon alfa-2b-njft (Besremi) as a category 1 preferred treatment option for a critical patient subset, according to a release by PharmaEssentia.
The updated NCCN Clinical Practice Guidelines in Oncology now lists the agent for high-risk ET patients who have had an inadequate response to or lost response to existing therapies. A category 1 recommendation signifies the highest level of evidence and uniform consensus among the NCCN's expert panels, signaling strong confidence in the regimen’s appropriateness.
This guideline update arrives as the
“This Category 1 designation is a major development for both patients and clinicians,” said Ko-Chung Lin, PhD, founder and CEO of PharmaEssentia. “It underscores the compelling clinical data and positions this therapy as an important potential option for high-risk patients with limited alternatives. We are ready to commercialize for this population, contingent upon FDA approval.”
The NCCN Guidelines are a cornerstone of US oncologic and hematologic practice, heavily relied upon by community oncologists for treatment decisions and frequently referenced by public and private payers in coverage determinations. This move provides clinicians with a timely, evidence-based framework to consider for eligible patients ahead of a potential FDA approval.
About Essential Thrombocythemia and the Unmet Need
ET is a rare, chronic myeloproliferative neoplasm characterized by the overproduction of platelets, which increases the risk of life-threatening thrombosis and bleeding. A subset of high-risk patients does not respond adequately to or becomes intolerant of first-line cytoreductive therapies such as hydroxyurea, creating a need for new, effective options.
