Posted by Michael Wonder on 18 Jul 2025
Genentech provides update on supplemental biologics license application for Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma
18 July 2025 - Genentech announced today that the US FDA issued a complete response letter for Genentech’s supplemental biologics license application for Columvi (glofitamab-gxbm) in combination with gemcitabine and oxaliplatin for the treatment of people with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for autologous stem cell transplant.
Based on the complete response letter, the STARGLO data do not provide sufficient evidence to support the proposed second-line DLBCL indication in the US patient population.
