FDA Rejects Genentech’s Bid to Expand Use of Lymphoma Drug Columvi
Genentech, a member of the Roche Group, announced Friday that the U.S. Food and Drug Administration (FDA) has rejected its application to expand the use of its cancer drug Columvi® (glofitamab-gxbm). The FDA issued a Complete Response Letter (CRL) for the supplemental Biologics License Application (sBLA), effectively declining to approve Columvi in combination with chemotherapy for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
