The US Food and Drug Administration has approved ropeginterferon alfa-2b-njft (BESREMi) for the treatment of adults with essential thrombocythemia (ET).
This marks the first new FDA-approved treatment for ET in nearly three decades, according to PharmaEssentia, the manufacturer of the drug.
The indication covers adult patients regardless of genotype or disease status, including newly diagnosed patients who have not previously received cytoreductive therapy. The FDA’s decision was primarily supported by clinical data from the global phase 3 SURPASS-ET clinical trial, which demonstrated that the therapy achieved durable modified European LeukemiaNet responses and robust hematologic control, according to a press release by PharmaEssentia.
“The approval of ropeginterferon alfa-2b-njft provides an important new treatment option that works at the source of the disease rather than solely managing symptoms,” said Ruben Mesa, MD, FACP, principal investigator of the SURPASS-ET trial.
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