BioCentury
ARTICLE | Company News

CHMP backs subcutaneous MabThera

January 25, 2014 1:38 AM UTC

EMA's CHMP backed approval of a subcutaneous formulation of MabThera rituximab from Roche (SIX:ROG; OTCQX:RHHBY) to treat follicular non-Hodgkin's lymphoma (NHL) and diffuse large B cell lymphoma (DLBCL). An IV formulation of the chimeric mAb against CD20 antigen is already approved in the EU for NHL, chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA) and DLBCL. According to Roche, a subcutaneous administration of MabThera takes about five minutes instead of about 2.5 hours with the IV administration. ...