FDA Approves Rituxan Hycela for Treating Certain Blood Cancers

The FDA has approved Genentech’s Rituxan Hycela for subcutaneous injection for the treatment of certain blood cancers. The new treatment is a combination of the monoclonal antibody in intravenous Rituxan (rituximab) and hyaluronidase human, an enzyme that assists in delivering rituximab beneath the skin.

Rituxan Hycela is approved for the treatment of previously untreated and relapsed or refractory follicular lymphoma, previously untreated diffuse large B-cell lymphoma, and previously treated or untreated chronic lymphocytic leukemia. The FDA approved of the drug because of results from multiple clinical studies that revealed non-inferior levels of rituximab in the blood with subcutaneous injections of Rituxan Hycela.

The efficacy outcomes of Rituxan Hycela often mirrored those of Rituxan. Since Rituxan Hycela requires less time to administer in a clinic, 77% of patients prefer it over Rituxan, according to one of the studies submitted to the FDA. Treatment time for Rituxan Hycela takes 5 to 7 minutes compared to the 1.5 hours or more it takes to administer Rituxan. However, Rituxan will continue to be available for treatment use, as patients may only receive Rituxan Hycela following at least one full dose of intravenous Rituxan.

“With today’s approval of Rituxan Hycela, people with 3 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,” Sandra Horning, MD, the chief medical officer and head of Global Product Development at Genentech, said in a statement.

Rituxan Hycela also had similar adverse reactions as Rituxan. Among the 3 types of blood cancer that Rituxan Hycela treats, the most common adverse reactions include infection and nausea.

“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,” concluded Horning.