Rituximab Infusion Approved for NHL


Get Permission

The FDA recently approved a 90-minute infusion for rituximab (Rituxan) starting at cycle 2 for patients with non-Hodgkin lymphoma (NHL) who did not experience a grade 3 or 4 infusion-related adverse reaction during cycle 1.  Patients with clinically significant cardiovascular disease and high circulating lymphocyte counts (≥ 5,000/µL) are not recommended to receive the faster infusion.

Phase III Trial

The approval was based on an open-label, single-arm, multicenter, phase III trial (RATE). The evaluable patient population was comprised of 363 previously untreated patients with follicular NHL or diffuse large B-cell lymphoma who had not experienced a grade 3 or 4 infusion-related reaction to rituximab in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) or CVP (cyclophosphamide, vincristine, prednisone) chemotherapy during cycle 1.  Patients received the faster infusion in cycle 2 and, if tolerated, in all subsequent cycles.  The faster infusion regimen consisted of rituximab administered over 90 minutes with 20% of the total dose given in the first 30 minutes, and remaining 80% of the total dose administered over the subsequent 60 minutes.

The trial’s primary endpoint was the incidence of grade 3 and 4 infusion-related reactions in patients who received rituximab by faster infusion at cycle 2. The incidence of grade 3 infusion-related reactions at cycle 2 was 1.1% (95% CI = 0.3–2.8), with no grade 4 or 5 infusion-related reactions reported. The RATE trial results are comparable to the results of infusion-related reactions during cycle 2 reported from trials using the standard infusion regimen. ■


Advertisement

Advertisement



;
Advertisement

By continuing to browse this site you permit us and our partners to place identification cookies on your browser and agree to our use of cookies to identify you for marketing. Read our Privacy Policy to learn more.