Subcutaneous Rituximab May Soon Be Approved for Certain Blood Cancers

Some lymphoma patients may soon be able to receive rituximab subcutaneously. A new study published in The Lancet Haematology is suggesting that intravenous and subcutaneous rituximab share similar efficacy and safety profiles. In addition, subcutaneous administration does not appear to compromise the anti-lymphoma activity of rituximab when given with chemotherapy, according to the latest findings from SABRINA, a two-stage, randomized, open-label phase III trial.

Currently, intravenous rituximab is the standard of care in B-cell non-Hodgkin lymphoma. However, a subcutaneous formulation could reduce patients' treatment burden and improve resource utilization in healthcare, according to the researchers. Andrew Davies of the University of Southampton, Southampton, UK et al found pharmacokinetic noninferiority of subcutaneous rituximab to intravenous rituximab in patients with follicular lymphoma with no new safety concerns.

In this study, 410 patients were randomly assigned to receive intravenous rituximab (n = 205) or subcutaneous rituximab (n = 205). The researchers found that the overall response at the end of induction was 84.9% in the intravenous group and 84.4% in the subcutaneous group. The frequency of adverse events was similar in both groups and the frequency of adverse events of grade 3 or higher was also similar. The most common grade 3 or higher adverse event was neutropenia (21% in the intravenous group vs 26% in the subcutaneous group).

In March of this year, the US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee voted unanimously (11 to 0) that the benefit-risk of rituximab/hyaluronidase for subcutaneous injection was favorable for the treatment of certain blood cancers. Included in this group of blood cancers are previously untreated follicular lymphoma, previously untreated diffuse large B-cell lymphoma (DLBCL), relapsed or refractory low grade or follicular lymphoma, and previously untreated and relapsed or refractory chronic lymphocytic leukemia (CLL).

The new co-formulation includes the same monoclonal antibody as intravenous rituximab and hyaluronidase, a molecule that helps to deliver medicine under the skin. The FDA is expected to make a decision on approval by June 26, 2017.

“Subcutaneous rituximab can be administered in 5 to 7 minutes compared to an hour and a half or more for intravenous Rituxan [rituximab],” said Sandra Horning, MD, who is the Chief Medical Officer and executive vice president of global development for Roche and Genentech, a member of the Roche Group in South San Francisco. “The significant reduction in administration time could especially benefit people with blood cancer who may receive years of treatment.”

This co-formulation has been available in the European Union since 2014 and it is approved in approximately 50 other countries worldwide. In the United States, rituximab is currently approved as an intravenous formulation for the treatment of people with previously untreated follicular lymphoma, previously untreated DLBCL, relapsed or refractory low grade or follicular lymphoma, and previously untreated and relapsed or refractory CLL.