Halozyme Therapeutics, Inc. (NASDAQ: HALO) announced today that the European Commission (EC) has approved Roche's new subcutaneous (SC) formulation of MabThera® (rituximab) for the treatment of patients with follicular lymphoma and diffuse large B-cell lymphoma. Following the approval of Herceptin SC in September 2013, this is the second European approval for a novel subcutaneous formulation of one of Roche's oncology products using Halozyme's patented Enhanze™ (recombinant human hyaluronidase) technology.
"Today's approval in the EU offers another treatment option for patients with common forms of non-Hodgkin lymphoma and is yet another validating milestone for our proprietary technology," said Dr. Helen Torley, President and Chief Executive Officer. "With an administration time of approximately five minutes compared to the approximately 2.5 hour infusion time for intravenous MabThera, this innovative formulation could potentially save time for patients, physicians and other health care providers in Europe."
The European approval was primarily based on data from the pivotal SABRINA study, which was recently published in the Lancet Oncology[i].
Roche has stated that they expect to begin launching MabThera SC in a number of European markets throughout 2014.
New CAR T-cell therapy shows promise against aggressive HER2+ breast cancer