FDA Approves New Time-Saving Treatment Option for People with Certain Blood Cancers

June 22nd, 2017

On June 22, the FDA approved RITUXAN HYCELA (rituximab and hyaluronidase human) for subcutaneous (under the skin) injection for the treatment of adults with the following blood cancers: 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 medicine under the skin.

News in brief

  • Treatment can be administered in five to seven minutes, compared to 1.5 hours or more for intravenous Rituxan.
  • The approval of Rituxan Hycela was based on results from clinical studies that together represented nearly 2,000 people.
  • One of the studies showed the majority (77 percent) of patients preferred RITUXAN HYCELA over intravenous Rituxan, with the most common reason being that administration required less time in the clinic.

Supporting Information

Sandra Horning, M.D.

"With today’s 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.”