FDA Accepts Roche's Columvi sBLA for Expanded Use in Lymphoma

Roche (RHHBY) announced that the FDA has accepted its supplemental biologics license application (sBLA) seeking expanded use of Columvi (glofitamab) for second-line relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) for review. The eligible population includes DLBCL patients who have received at least one prior line of treatment (second-line setting) and are not candidates for autologous stem cell transplant. A final decision from the regulatory body is expected on July 20, 2025.Please note ...