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News
The FDA has approved Besremi (ropeginterferon alfa-2b-njft) for adults with essential thrombocythemia (ET), marking the first new treatment for this rare blood cancer in nearly three decades. The approval was backed by the phase 3 SURPASS-ET trial, where Besremi achieved a 37.4% durable response rate versus just 3.6% with anagrelide. The therapy works at the disease's source, not just managing symptoms.
The FDA has approved Besremi (ropeginterferon alfa-2b-njft) for adults with essential thrombocythemia (ET), a rare blood disorder in which the bone marrow overproduces platelets, raising the risk of blood clots and bleeding. This marks the first new FDA-approved ET therapy in nearly 30 years and is indicated regardless of genotype or disease status — including newly diagnosed patients who haven't yet received cytoreductive therapy.
The approval was based on the phase 3 SURPASS-ET trial, which enrolled 174 adults with ET who had inadequate responses to or couldn't tolerate hydroxyurea. Besremi significantly outperformed anagrelide on durable clinical response, offering a meaningful new option for a patient population with long-standing unmet needs.
By the Numbers:
Why it matters: For patients and physicians who've had virtually no new treatment options for ET in three decades, Besremi represents a significant step forward — one that targets the underlying disease rather than just controlling blood counts.
