FDA Approves Subcutaneous RITUXAN® Formulation for CD20-Positive Hematologic Malignancies

The US FDA on June 22, 2017, granted regular approval to the combination of RITUXAN® (Rituximab) and Hyaluronidase human (RITUXAN HYCELA®) for adult patients with Follicular Lymphoma, Diffuse Large B-Cell Lymphoma, and Chronic Lymphocytic Leukemia. This Subcutaneous formulation of RITUXAN® utilizes ENHANZE®, a drug delivery technology platform, which removes limitations on the volume of biologics and drugs that can be delivered Subcutaneously, thereby significantly reducing the time required for drug administration. The approval of RITUXAN HYCELA® was based on several randomized clinical trials that demonstrated Non-inferior pharmacokinetics of Subcutaneous RITUXAN HYCELA® compared with IV RITUXAN®, as well as comparable efficacy and safety results.