The European Commission approved a new subcutaneous (SC) formulation of Roche’s MabThera (rituximab) for patients with common forms of non-Hodgkin lymphoma. The approval was the second in six months for an SC formulation of a Roche oncology product that uses Halozyme Therapeutics’ Enhanze™ (recombinant human hyaluronidase or rHuPH20) technology.
Specifically, MabThera SC is indicated for patients with follicular lymphoma and diffuse large B-cell lymphoma. Roche said it expects to begin launching MabThera SC in a number of European markets throughout 2014.
The European approval was based primarily on data from the pivotal SABRINA study, recently ublished in The Lancet Oncology. That data showed that SC administration of MabThera enabled the delivery of the drug over approximately five minutes without compromising its proven efficacy and safety.
“We believe that the faster five minute administration will significantly improve the treatment experience for patients and providers compared to the approximate 2.5 hour infusion time for intravenous MabThera,” Sandra Horning, M.D., CMO and head, global product development, for Roche, said in a statement.
MabThera—marketed as Rituxan in the U.S., Japan, and Canada—is a monoclonal antibody that binds to the CD20 antigen on the surface of normal and malignant B-cells, then attacks and kills those cells by recruiting the body’s natural defenses. Discovered by Biogen Idec, MabThera won its first FDA approval in 1997 for treatment of relapsed indolent non-Hodgkin Lymphoma (NHL). The drug won similar approval in Europe in 1998, and according to Roche has since been used to treat more than 2.7 million people with specific blood cancers.
The European SC approval comes more than seven years after the companies signed an exclusive licensing agreement allowing Roche to use Halozyme's patented Enhanze™ technology in biological therapeutic compounds. Roche has opted to explore use of rHuPH20 for up to a total of five exclusive targets. Roche retains the option to apply rHuPH20 to three additional targets through the payment of annual license maintenance fees.
Roche agreed to pay Halozyme additional milestones as well as royalties on product sales for Herceptin SC, MabThera SC and any other product candidates successfully developed and commercialized under the agreement—subject to successful achievement of undisclosed clinical, regulatory, and sales milestones. In December 2012, Roche triggered a $4 million milestone payment to Halozyme after submitting a line extension application to EMA for MabThera SC.
The first Roche oncology product using Halozyme’s Enhanze to be approved in Europe was Herceptin SC, which was approved in September 2013.
Roche’s Genentech subsidiary and Biogen Idec collaborate on Rituxan in the U.S., while Roche markets the drug elsewhere in the world except Japan, where MabThera is co-marketed by Chugai and Zenyaku Kogyo.