The Center for Drug Evaluation (CDE) in China has accepted for review an additional indication approval filing submitted by Swiss pharmaceutical giant Roche (SWX: ROG) for its drug Columvi (glofitamab). The filing suggests a potential use in combination with gemcitabine and oxaliplatin for the treatment of diffuse large B-cell lymphoma (DLBCL) in patients who have received prior treatment and are not eligible for autologous stem cell transplantation, as informed by recent clinical trials.
Columvi, a bispecific antibody designed to target both CD20 and CD3, received its initial approval in China in November of the previous year. It was granted for the treatment of recurrent or refractory DLBCL in patients who had already undergone at least two lines of systemic treatment.- Flcube.com
