FDA Approves Faster Rituximab Infusion for Some Patients

The U.S. Food and Drug Administration has approved a shorter, 90-minute infusion of rituximab beginning at the second cycle for patients being treated for certain non-Hodgkin’s lymphomas who did not experience a grade 3 or 4 infusion-related adverse reaction during the initial cycle.

This quicker infusion is not recommended for patients with clinically significant cardiovascular disease or high circulating lymphocyte counts (>5000/mcL).

The FDA's approval comes on account of an open-label, single-arm, multi-center, phase III trial known as RATE. That trial involved 363 previously untreated patients with either follicular lymphoma or diffuse large B-cell lymphoma who didn't experienced a grade 3 or 4 infusion-related reaction to rituximab along with CHOP or CVP combination chemotherapy during the first cycle. In the second cycle, patients received the faster infusion. If they tolerated it, they were given this infusion for all subsequent cycles.

The faster infusion regimen consisted of rituximab given over 90 minutes with one-fifth of the total dose given in the first 30 minutes, and the balance of the total dose administered over the following 60 minutes.

Source: LLS