FDA Approves Subcutaneous Rituximab and Hyaluronidase Human for Blood Cancers
The FDA granted approval to rituximab and hyaluronidase human as a subcutaneous injection for the treatment of follicular lymphoma, chronic lymphocytic leukemia, and DLBCL.
The US Food and Drug Administration (FDA) granted approval to rituximab and hyaluronidase human as a subcutaneous injection for the treatment of follicular lymphoma (FL), chronic lymphocytic leukemia (CLL), and diffuse large B cell lymphoma (DLBCL) in adult patients.1
The newly approved treatment is a combination product of rituximab, a humanized chimeric anti-CD20 monoclonal antibody, and hyaluronidase human, a dispersion agent which allows for increased absorption of subcutaneously administered medication.
The treatment is also indicated as a single agent for relapsed or refractory FL and previously untreated FL in combination with first-line chemotherapy.
The subcutaneous formulation shortens the time of administration from several hours of intravenous (IV) infusion to 5 to 7 minutes.
Patients who are candidates for this drug combination should begin treatment only after receiving at least 1 complete dose of IV rituximab. Multiple randomized clinical studies established comparable safety and clinical efficacy, as well as non-inferior concentration levels after subcutaneous administration compared with IV rituximab.
The most common adverse events (AE) (occurring in at least 20% of patients) observed with subcutaneous administration varied based on indication.
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The most common AEs in FL were infection, neutropenia, nausea, constipation, cough, and fatigue. The most common AEs in DLBCL were infection, neutropenia, alopecia, nausea, and anemia. The most common AEs in CLL were infection, neutropenia, nausea, thrombocytopenia, pyrexia, vomiting, and injection site erythema.
- FDA approves rituximab plus hyaluronidase combination for Treatment of FL, DLBCL, and CLL [news release]. Silver Spring, MD: US Food and Drug Administration; June 22, 2017. https://www.fda.gov/Drugs/InformationOnDrugs /ApprovedDrugs/ucm564235.htm. Accessed June 22, 2017.