MacroGenics said the U.S. FDA has placed a partial clinical hold on its Phase 2 LINNET trial of lorigerlimab in gynecologic cancers, halting enrollment of new patients while allowing current participants to continue treatment. The action follows the company’s notification of a temporary enrollment pause after recent serious safety events, including Grade 4 thrombocytopenia, myocarditis, neutropenia with septic shock, and one Grade 5 event. MacroGenics said it is working with the FDA to resolve the hold and resume enrollment.
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