FDA approves Rituxan Hycela in multiple blood indications

23 June 2017

The US Food and Drug Administration yesterday approved Rituxan Hycela, the combination of Genentech’s Rituxan (rituximab) and Halozyme’s (Nasdaq: HALO) hyaluronidase human Enhanze technology for adult patients with follicular lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia.

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:

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