ARTICLE | Clinical News

Subcutaneous rituximab regulatory update

January 27, 2014 8:00 AM UTC

EMA's CHMP backed approval of a subcutaneous formulation of MabThera rituximab from Roche to treat follicular non-Hodgkin's lymphoma (NHL) and diffuse large B cell lymphoma (DLBCL). Roche already markets an IV formulation of the chimeric mAb against CD20 antigen in the EU for NHL, chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA) and DLBCL. According to Roche, a subcutaneous administration of MabThera takes about 5 minutes instead of about 2.5 hours with the IV administration. The subcutaneous formulation uses Halozyme's Enhanze recombinant human hyaluronidase ( rHuPH20) drug delivery technology. ...