FDA Approves BESREMi as First New Treatment for Essential Thrombocythemia in Nearly Three Decades

The U.S. Food and Drug Administration (FDA) has approved ropeginterferon alfa-2b-njft (BESREMi) for adults with essential thrombocythemia (ET), a rare blood cancer characterized by the overproduction of platelets. This marks the first new FDA-approved treatment for ET in nearly 30 years and is applicable to adults regardless of their genetic profile or prior cytoreductive therapy. The approval was supported by results from the Phase 3 SURPASS-ET clinical trial, which demonstrated superior durable response rates compared to anagrelide and reduced thromboembolic events.