Posted by Michael Wonder on 08 Dec 2025
Incyte’s first in class mutCALR targeted monoclonal antibody, INCA033989, granted breakthrough therapy designation by US FDA
7 December 2025 - Incyte today announced that the US FDA has granted breakthrough therapy designation to INCA033989, a first in class mutant calreticulin (mutCALR)-targeted monoclonal antibody, for the treatment of patients with essential thrombocythaemia harbouring a Type 1 CALR mutation who are resistant or intolerant to at least one cytoreductive therapy.
The FDA breakthrough therapy designation was supported by the early Phase 1 data evaluating INCA033989 in essential thrombocythemia patients with a Type 1 CALR mutation available at the time of submission.
