The U.S. Food and Drug Administration has approved the subcutaneous injection formula of rituximab and hyaluronidase for the treatment of adults with follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), and chronic lymphocytic leukemia (CLL).
This approval offers patients a subcutaneous route of rituximab administration that shortens the administration time from several hours to seven minutes. The new product also provides for flat dosing.
The approval was based on results from multiple randomized clinical trials comparing the rituximab-based combination with rituximab monotherapy, in which the rituximab combination demonstrated non-inferior rituximab trough concentrations levels, compared with intravenous rituximab 375 mg/m2 and intravenous rituximab 500 mg/m2 as well as comparable efficacy and safety results.
The new product's indication covers the following previously approved indications for intravenous rituximab:
- as a single agent for relapsed/refractory FL
- in combination with firstline chemotherapy for previously untreated FL
- as single-agent maintenance therapy for patients with FL who achieved a complete or partial response to rituximab in combination with chemotherapy
- as a single agent after firstline cyclophosphamide, vincristine, and prednisone for non-progressing FL
- in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens for previously untreated DLBCL
- in combination with fludarabine and cyclophosphamide for previously untreated and previously treated CLL
Source: FDA news release, June 22, 2017.