RITUXAN HYCELA approved by FDA for subcutaneous injection in certain blood cancers

Genentech, a member of the Roche Group announced that the U.S. Food and Drug Administration (FDA) approved RITUXAN HYCELA (rituximab and hyaluronidase human) for subcutaneous (under the skin) injection for the treatment of adults with the blood cancers like previously untreated and relapsed or refractory follicular lymphoma, previously untreated diffuse large B-cell lymphoma (DLBCL), and previously untreated and previously treated chronic lymphocytic leukemia (CLL).

This new treatment includes the same monoclonal antibody as intravenous Rituxan (rituximab) in combination with hyaluronidase human, an enzyme that helps to deliver rituximab under the skin.

Sandra Horning, M.D., chief medical officer and head of Global Product Development said, "With this approval of RITUXAN HYCELA, people with three of the most common blood cancers now have a new treatment option which provides efficacy comparable with intravenous Rituxan and can be delivered under the skin in minutes instead of hours through IV infusion. People who benefit from Rituxan may receive years of repeated treatments for their blood cancer, so an option that reduces the administration time can be important."

The FDA approval is based on results from clinical studies, which demonstrated that subcutaneous administration of RITUXAN HYCELA resulted in non-inferior levels of rituximab in the blood (pharmacokinetics) and comparable clinical efficacy outcomes compared to intravenous Rituxan.