FDA Approves Rituxan Hycela for Subcutaneous Injection in Certain Blood Cancers

SC formulation can be administered within five to seven minutes

The FDA has given the go-ahead to Rituxan Hycela (rituximab and hyaluronidase human, Genentech) for subcutaneous (SC) 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 (IV) Rituxan (rituximab) in combination with hyaluronidase human, an enzyme that helps to deliver rituximab under the skin.

The FDA’s approval was based on results from clinical studies in which the SC administration of Rituxan Hycela resulted in noninferior levels of rituximab in the blood and comparable clinical efficacy outcomes compared with IV Rituxan. In one of the studies, most patients (77%) preferred SC Rituxan Hycela over IV Rituxan, with the most common reason being that administration required less time in the clinic. Patients can receive Rituxan Hycela only after at least one full dose of Rituxan.

The most common adverse events (AEs) associated with Rituxan Hycela in patients with follicular lymphoma included infections, neutropenia, nausea, constipation, cough, and fatigue. The most common AEs observed in patients with DLBCL included infections, neutropenia, alopecia, nausea, and anemia. The most common AEs occurring in patients with CLL included infections, neutropenia, nausea, thrombocytopenia, pyrexia, vomiting, and erythema at the injection site.

Rituxan Hycela will be available in the United States within one to two weeks, and Rituxan will continue to be available.

Rituxan Hycela is a combination of rituximab and Halozyme Therapeutics’ proprietary hyaluronidase human. Rituximab is the same monoclonal antibody in Rituxan and is designed to attach to CD20, a protein found on certain types of B cells. It is thought to work by attacking targeted cells together with the body’s immune system. Halozyme’s hyaluronidase human is an enzyme that facilitates the delivery of a large volume of medication under the skin.

Rituxan Hycela can be administered within five to seven minutes, compared with 1.5 hours or more for IV Rituxan. All patients must first receive at least one full dose of Rituxan by IV infusion without severe adverse reactions before they can receive SC Rituxan Hycela because of the increased risk of certain severe adverse reactions during the first infusion.

Rituxan was discovered by Biogen and is part of a collaboration between Genentech and Biogen in the U.S.

Source: Genentech; June 23, 2017.