FDA Approves New Combination Therapy for Several Types of Lymphoma

The US Food and Drug Administration has approved the combination of rituximab and hyaluronidase human for the treatment of follicular lymphoma (FL), diffuse large B-cell lymphoma, and chronic lymphocytic leukemia in adult patients.

Rituximab can now be administered subcutaneously, which shortens the time of administration from several hours with an intravenous infusion to 5 to 7 minutes.
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For patients with follicular lymphoma and diffuse large B-cell lymphoma, the recommended doses are 1400 mg of rituximab and 23,400 units of hyaluronidase human, and 1600 mg of rituximab and 26,800 units of hyaluronidase human. Patients with chronic lymphocytic leukemia are recommended to receive 1600 mg of rituximab and 26,800 units of hyaluronidase human. The new combination should be initiated only after patients have received at least 1 intravenous infusion of rituximab.  

Data from multiple randomized clinical trials were used to determine the efficacy and safety of rituximab. The trials demonstrated that trough concentrations (Ctrough) levels for rituximab/hyaluronidase human at 1400 mg/23,400 units compared with intravenous infusion of 375 mg/m2 of rituximab was non-inferior, and Ctrough levels of rituximab/hyaluronidase human at 1600 mg/26,800 units was non-inferior when compared with intravenous rituximab at 500 mg/m2.

Common adverse events observed in patients with follicular lymphoma (20% or more) included infectious, neutropenia, nausea, constipation, cough, and fatigue. In patients with diffuse large B-cell lymphoma, the most common adverse events included infections, neutropenia, alopecia, nausea, and anemia. Infections, neutropenia, nausea, thrombocytopenia, pyrexia, vomiting, and infection site erythema were the most common adverse events observed in patients with chronic lymphocytic leukemia.

—Melissa Weiss

Reference:

FDA approves rituximab plus hyaluronidase combination for Treatment of FL, DLBCL and CLL [press release]. FDA. June 22, 2017. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm564235.htm. Accessed June 23, 2017.