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New Treatment Approved for FL, DLBCL, and CLL
FDA news release; 2017 Jun 22
The FDA has approved Rituxan Hycela (rituximab and hyaluronidase human) to treat follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), and chronic lymphocytic leukemia (CLL).
Indications: Rituxan Hycela is a combination of rituximab, a CD20-directed cytolytic antibody, and hyaluronidase human, an endoglycosidase, indicated for the treatment of adult patients with FL, DLBCL, and CLL.
Dosage and Administration:
- FL/DLBCL: 1,400 mg rituximab/23,400 units hyaluronidase human subcutaneously.
- CLL: 1,600 mg rituximab/26,800 units hyaluronidase human subcutaneously.
Efficacy and safety: Approval is based on randomized trials demonstrating non-inferiority compared with IV rituximab, as well as comparable efficacy and safety.
Side effects/risks:
- FL: Infections, neutropenia, nausea, constipation, cough, and fatigue.
- DLBCL: Infections, neutropenia, alopecia, nausea, and anemia.
- CLL: Infections, 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: FDA. June 22, 2017. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm564235.htm. Accessed June 26, 2017.
Rituxan Hycela [package insert]. South San Francisco, CA: Genentech USA, Inc. 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761064s000lbl.pdf. Accessed June 26, 2017.