On June 22, 2017, the FDA approved the combination of rituximab and hyaluronidase human (Rituxan Hycela; Genentech) for the treatment of adults with follicular lymphoma, diffuse large B-cell lymphoma (DLBCL), or chronic lymphocytic leukemia (CLL).
Specifically, this approval covers indications that were previously approved for rituximab alone, including patients with previously untreated or nonprogressing relapsed or refractory follicular lymphoma; previously untreated DLBCL; and previously treated and untreated CLL.
This approval gives patients a subcutaneous route for receiving rituximab that shortens its administration time by 5 to 7 minutes (compared with the several hours that an intravenous infusion can take) and provides the option of flat dosing.
The FDA’s approval was based on multiple randomized clinical trials that demonstrated the noninferiority of rituximab trough concentration levels in the combination therapy to those of intravenous rituximab, as well as the comparable efficacy and safety of the combination therapy and rituximab monotherapy.
In patients with follicular lymphoma, the most common (≥20%) adverse events associated with the combination therapy include infections, neutropenia, nausea, constipation, cough, and fatigue. For patients with DLBCL, the most common (≥20%) adverse events include infections, neutropenia, alopecia, nausea, and anemia. In patients with CLL, the most common (≥20%) adverse events are infections, neutropenia, nausea, thrombocytopenia, pyrexia, vomiting, and injection-site erythema.