publication date: Jun. 23, 2017

Drugs and Targets FDA approves Rituxan Hycela for DLBL and CLL

FDA 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 agent is sponsored by Genentech, a member of the Roche Group.

The approval provides patients a subcutaneous route of rituximab administration that shortens the administration time to 5 to 7 minutes, as compared to intravenous infusion that can take several hours. This new product also provides for flat dosing.

The approval specifies the combination is indicated for the following previously approved indications for Rituxan:

Relapsed or refractory, follicular lymphoma 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 or other anthracycline-based chemotherapy regimens.

Previously untreated and previously treated CLL in combination with fludarabine and cyclophosphamide.

Rituxan Hycela is not indicated for the treatment of non-malignant conditions.

“People who benefit from Rituxan may receive years of repeated treatments for their blood cancer, so an option that … Continue reading FDA approves Rituxan Hycela for DLBL and CLL

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