The FDA’s Oncologic Drugs Advisory Committee has voted unanimously (11 to 0) that the risk–benefit ratio of rituximab/hyaluronidase for subcutaneous (SC) injection (Halozyme Therapeutics) was favorable for patients in the proposed indications of follicular lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia. The FDA action date is June 26, 2017.
Upon approval, subcutaneous rituximab could reduce the administration time for the rituximab portion of patients’ treatment to five to seven minutes compared with an hour and a half or more for intravenous administration, according to Halozyme.
Rituximab coformulated with recombinant human hyaluronidase was approved in Europe in 2014 and is currently marketed as the SC formulation of MabThera (rituximab) in approximately 50 countries worldwide.
Source: Halozyme Therapeutics; March 29, 2017.