The FDA granted accelerated approval for glofitamab-gxbm (Columvi, Genentech) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response in the phase 1/2 NP30179 study.
The accelerated approval is based
JUNE 18, 2023