On March 29, 2017 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported that an Oncologic Drug Advisory Committee of the U.S. Food and Drug Administration voted 11 to 0 that the benefit/risk of rituximab/hyaluronidase for subcutaneous (under the skin) injection was favorable for patients in the proposed indications of follicular lymphoma, diffuse large B-cell lymphoma and chronic lymphocytic leukemia (Press release, Halozyme, MAR 29, 2017, View Source [SID1234518305]). The FDA action date is June 26, 2017. Schedule your 30 min Free 1stOncology Demo! "We are pleased with the support from today’s advisory committee," said Dr. Helen Torley, president and chief executive officer. "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."
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Efficacy, safety, pharmacokinetic and patient-reported outcome data from five clinical studies presented by Genentech, a member of the Roche Group, at today’s advisory committee meeting supported the rituximab SC application.
Rituximab co-formulated with Halozyme’s recombinant human hyaluronidase was approved in Europe in 2014 and is currently marketed as the subcutaneous (SC) formulation of MabThera (rituximab) in approximately 50 countries worldwide.