FDA Approves Rituximab Plus Hyaluronidase Combination for Treatment of Certain Hematologic Malignancies
On June 22, 2017, the U.S. Food and Drug Administration granted regular approval to the combination of rituximab and hyaluronidase human (Rituxan Hycela) for adult patients with follicular lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia.
The approval provides a subcutaneous route of rituximab (Rituxan) administration, which shortens the administration time to 5 to 7 minutes, as compared to intravenous infusion, which can take several hours. This new product also enables flat dosing.
The approval specifies the combination is indicated for the following previously approved indications for rituximab:
- Relapsed or refractory follicular lymphoma as a single agent
- Previously untreated follicular lymphoma in combination with first-line chemotherapy and, in patients achieving a complete or partial response to rituximab in combination with chemotherapy, as single-agent maintenance therapy
- Nonprogressing (including stable disease) follicular lymphoma as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy
- Previously untreated diffuse large B-cell lymphoma (DLBCL) in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens
- Previously untreated and previously treated CLL in combination with fludarabine and cyclophosphamide (FC).
Rituximab plus hyaluronidase human is not indicated for the treatment of nonmalignant conditions.
Clinical Trial Details
Approval was based on multiple randomized clinical trials demonstrating the following findings: (1) noninferior rituximab trough concentration levels for rituximab plus hyaluronidase human at 1,400 mg/23,400 units compared to intravenous rituximab at 375 mg/m2, (2) noninferior rituximab trough concentration levels for rituximab plus hyaluronidase human at 1,600 mg/26,800 units compared to intravenous rituximab at 500 mg/m2, and (3) comparable efficacy and safety results of the two products. Trial results are provided in the drug prescribing information.
The most common adverse events (≥ 20%) observed in patients with follicular lymphoma include infections, neutropenia, nausea, constipation, cough, and fatigue. The most common adverse events (≥ 20%) observed in patients with DLBCL include infections, neutropenia, alopecia, nausea, and anemia. The most common adverse events (≥ 20%) observed in patients with CLL were infections, neutropenia, nausea, thrombocytopenia, pyrexia, vomiting, and injection site erythema.
The recommended doses are 1,400 mg of rituximab and 23,400 units of hyaluronidase human for follicular lymphoma and DLBCL and 1,600 mg of rituximab and 26,800 units of hyaluronidase human for CLL. Clinicians should refer to the prescribing information for specific dosing schedules. Rituximab plus hyaluronidase human treatment should be initiated only after patients have received at least one full dose of a rituximab product by intravenous infusion.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
