FDA Approves Rituximab and Human Hyaluronidase Combination for Follicular Lymphoma, Diffuse Large B-Cell Lymphoma and Chronic Lymphocytic Leukemia

On 22 June 2017, the United States Food and Drug Administration FDAapproved combined rituximab and human hyaluronidase (trade name Rituxan Hycela) to treat adults with follicular lymphoma, diffuse large B-cell lymphoma and chronic lymphocytic leukemia.

Compared with hours-long intravenous rituximab infusion, this approval permits subcutaneous (under-the-skin) administration, shortening delivery to 5 to 7 minutes. The new product also provides fixed dosing.

Approved Indications for Combined Rituximab and Human Hyaluronidase:

• As a single agent in relapsed or treatment-resistant follicular lymphoma,
• With first-line chemotherapy in previously untreated follicular lymphoma, and as single-agent maintenance in patients achieving a complete or partial response to prior rituximab plus chemotherapy,
• As a single agent in stable follicular lymphoma after first-line cyclophosphamide, vincristine and prednisone (CVP) chemotherapy,
• With cyclophosphamide, doxorubicin, vincristine, prednisolone (CHOP) or other anthracycline-based chemotherapy in previously untreated diffuse large B-cell lymphoma,
• With fludarabine and cyclophosphamide for previously untreated and previously treated chronic lymphocytic leukemia. Combined rituximab and human hyaluronidase is not indicated for malignant -free diseases, that is, nonmalignant conditions.

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Approval Is Based on Multiple Randomized Clinical Trials:

• Comparing rituximab/human hyaluronidase at concentrations no lower than 1,400 mg/23,400 units with intravenous rituximab 375 mg/m2,
• Comparing rituximab/human hyaluronidase at concentrations no lower than 1,600 mg/26,800 units with intravenous rituximab 500 mg/m2,
• With comparable efficacy and safety results for the two products.

The most common adverse effects (≥% 20) in follicular lymphoma patients are infections, febrile low white blood cell counts (neutropenia), nausea, constipation , cough and fatigue. In diffuse large B-cell lymphoma, the most common adverse effects (≥% 20) are infections, febrile low white blood cell counts (neutropenia), hair loss, nausea and low red blood cell counts (anemia). In chronic lymphocytic leukemia, the most common adverse effects (≥% 20) are infections, febrile low white blood cell counts (neutropenia), nausea, low platelets (thrombocytopenia), fever, vomiting and blood accumulation at the injection site (erythema).

Recommended doses for follicular lymphoma and diffuse large B-cell lymphoma are rituximab 1400 mg and human hyaluronidase 23,400 units; for chronic lymphocytic leukemia, rituximab 1600 mg and human hyaluronidase 26.800 units. Combined rituximab and human hyaluronidase treatment should begin after patients have received at least one full intravenous rituximab dose.