The FDA granted regular approval to the combination of rituximab and hyaluronidase human for adult patients with follicular lymphoma (FL), diffuse large B-cell lymphoma, and chronic lymphocytic leukemia (CLL).
The approval provides patients a subcutaneous route of rituximab administration that shortens the administration time to 5-7 minutes as compared to IV infusion that can take several hours.
The approval specifies the combination is indicated for the following previously approved indications for rituximab: relapsed or refractory FL as a single agent; previously untreated FL 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; non-progressing (including stable disease), FL as a single agent after first-line cyclophosphamide, vincristine, and prednisone chemotherapy; previously untreated diffuse large B-cell lymphoma in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP), or other anthracycline-based chemotherapy regimens; and previously untreated and previously treated CLL in combination with fludarabine and cyclophosphamide.