FDA approved Defitelio (defibrotide sodium) to treat adults and children who develop hepatic veno-occlusive disease with additional kidney or lung abnormalities after hematopoietic stem cell transplantation. This is the first FDA-approved therapy for treatment of severe hepatic VOD. Hepatic VOD can occur in patients who receive chemotherapy and HSCT. The efficacy of Defitelio was investigated...
In a unanimous vote, the FDA Oncologic Drugs Advisory Committee advised the agency to accept the metric of “minimal residual disease,” or MRD, as a basis for accelerated approvals of therapies in all settings of multiple myeloma.
