In collaboration with the Food and Drug Administration (FDA), and as a service to our members, ASH provides information about newly approved therapies for patients. This allows the agency to inform hematologists and professionals in hematology-related fields of recent approvals in a timely manner. Included in the message below is a link to the product label, which provides the relevant clinical information on the indication, contraindications, dosing, and safety. In providing this information, ASH does not endorse any product or therapy and does not take any position on the safety or efficacy of the product or therapy described. The following is a message from the FDA’s Office of Hematology and Oncology Products:
On October 19, 2012, the U. S. Food and Drug Administration approved a 90-minute infusion for rituximab (Rituxan® Injection, Genentech, Inc.) starting at Cycle 2 for patients with non-Hodgkin’s 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 (>5000/mcL) are not recommended to receive the faster infusion.
The approval was based on an open-label, single-arm, multi-center, phase 3 trial (RATE). The evaluable patient population was comprised of 363 previously untreated patients with follicular NHL or diffuse large B-cell lymphoma (DLBCL) who had not experienced a grade 3 or 4 infusion-related reaction (IRR) to rituximab in combination with CHOP or CVP 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 IRRs in patients who received rituximab by faster infusion at Cycle 2. The incidence of grade 3 IRRs at Cycle 2 was 1.1% (95% CI: 0.3, 2.8)], with no grade 4 or 5 IRRs reported. The RATE trial results are comparable to the results of IRRs during cycle 2 reported from trials using the standard infusion regimen.
Full prescribing information is available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103705s5367s5388lbl.pdf
Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).