The U.S. FDA's Oncologic Drug Advisory Committee recommended Rituxan co-formulated with Halozyme Therapeutics Inc.'s recombinant human hyaluronidase for subcutaneous injection in treating certain cancers.
Rituxan was discovered by Biogen and is part of a collaboration between Genentech, a member of the Roche Holding Ltd., and Biogen Inc. in the U.S.
The committee voted that the benefit/risk of the drug formulation was favorable for patients with follicular lymphoma, diffuse large B-cell lymphoma and chronic lymphocytic leukemia. The recommendation was based on a review of results from a clinical development program comprising five studies that together represented more than 2,000 people across key blood cancers for which intravenous Rituxan is approved.
The studies demonstrated that subcutaneous administration of the co-formulation resulted in noninferior levels of rituximab in the blood and consistent clinical efficacy and safety outcomes compared to intravenous Rituxan.
Rituximab co-formulated with recombinant human hyaluronidase was approved in Europe in 2014 and is marketed as the subcutaneous formulation of MabThera in about 50 countries worldwide.
In the U.S., Rituxan is approved as an intravenous formulation for the treatment of people with previously untreated follicular lymphoma, previously untreated diffuse large B-cell lymphoma, relapsed or refractory low-grade or follicular lymphoma, and previously untreated and relapsed or refractory chronic lymphocytic leukemia.
"Upon approval, subcutaneous rituximab would offer a new treatment option for U.S. patients that could reduce the administration time for the Rituximab portion of their treatment to 5 to 7 minutes as compared with an hour and a half or more for intravenous administration," said Halozyme's president and CEO Helen Torley.
The FDA is expected to make a decision on approval by June 26.