Investigators sought to determine the incidence of BLI on patients with cancer receiving bleomycin-containing regimens.
Although rituximab is well-tolerated by children, infections are common and time to recovery of B lymphocytes, prolonged.
The approval was based on data from the open-label, multi-cohort phase 2 UNITY-NHL Trial.
The biosimilar has been approved for the treatment of Non-Hodgkin’s Lymphoma, Chronic Lymphocytic Leukemia, Granulomatosis with Polyangiitis, and Microscopic Polyangiitis.
Initial treatment of mantle cell lymphoma with lenalidomide and rituximab may result in significant complete response rates and durable lengths of remission.