FDA Fast Tracks Gamgertamig for ITP

The U.S. Food and Drug Administration (FDA) has granted fast track designation to gamgertamig (OM336) for the treatment of immune thrombocytopenia (ITP) and cold and warm autoimmune hemolytic anemia (AIHA). Gamgertamig is a BCMAxCD3 bispecific T-cell engager antibody being developed by Ouro Medicines as an “immune reset” therapeutic. The drug aims to deliver durable disease control while avoiding prolonged, nonspecific immunosuppression by directing T cell-dependent cytotoxicity toward BCMA-expressing cells implicated in pathogenic autoantibody production. 

Gamgertamig is being assessed in an open-label, multinational basket study (NCT07083960) enrolling adults with active ITP, relapsed/refractory AIHA or both, in the United States and Australia. The study is assessing the safety, tolerability and pharmacokinetics following subcutaneous administration, with a primary endpoint at week 12. Dosing has been completed in the first cohort, and enrollment is ongoing in subsequent cohorts.