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INCA033989 granted breakthrough therapy designation by the FDA for ET
On December 7, 2025, the U.S. Food and Drug Administration (FDA) granted breakthrough therapy designation to INCA033989, a first-in-class mutant calreticulin (mutCALR)-targeted monoclonal antibody therapy, for the treatment of patients with essential thrombocythemia (ET) with a Type 1 CALR mutation who are resistant or intolerant to ≥1 cytoreductive therapy.1
This designation is supported by preliminary results from the ongoing phase I studies, INCA33989-101 (NCT05936359) and INCA33989-102 (NCT06034002), which were presented at the 2025 European Hematology Association (EHA) Congress and previously covered by the MPN Hub.1 INCA033989 was well tolerated and resulted in rapid, sustained normalization of platelet counts.1 Updated results were presented at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, December 6–9, 2025, Orlando, US.1
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