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), or chronic lymphocytic leukemia (CLL).
The drug can be administered only to patients who have received at least one full dose of intravenous (IV) rituximab. The approval offers patients a subcutaneous route of rituximab administration that shortens administration time from several hours to five to seven minutes. The new product also allows for flat dosing.
Its indications cover the following previously approved indications for IV rituximab:
- relapsed/refractory FL, as a single agent
- previously untreated FL, in combination with firstline chemotherapy; and, in patients achieving a complete or partial response to rituximab in combination with chemotherapy, as single-agent maintenance therapy
- non-progressing (including stable disease) FL, as a single agent after firstline cyclophosphamide, vincristine, and prednisone chemotherapy
- previously untreated DLBCL, in combination with cyclophosphamide, doxorubicin, vincristine, prednisone, or other anthracycline-based chemotherapy regimens
- previously untreated and previously treated CLL, in combination with fludarabine and cyclophosphamide
The approval was based on multiple randomized clinical trials in which rituximab and hyaluronidase demonstrated rituximab trough concentration (Ctrough) levels that were non-inferior to IV rituximab 375 mg/m2 and IV rituximab 500 mg/m2. Efficacy and safety outcomes were also comparable between the two products.
Source: U.S. Food and Drug Administration news release, June 22, 2017.