FDA imposes partial hold on Gossamer lymphoma drug trial after patient deaths.
The FDA has placed a partial clinical hold on Gossamer Bio's Phase Ib/II study of its BTK inhibitor for central nervous system lymphoma after two patient deaths occurred in the trial. The hold was placed due to serious adverse events, including atrial fibrillation, a sudden death event, and a fatal intracranial hemorrhage. Gossamer Bio had previously paused the trial due to a "benefit/risk profile."