FDA Grants Accelerated Approval to Glofitamab for Patients With R/R Diffuse Large B-Cell Lymphoma

On June 15, 2023, the US Food and Drug Administration (FDA) granted approval to glofitamab-gxbm for the treatment of patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL), not otherwise specified or large B-cell lymphoma (LBCL) arising from follicular lymphoma (FL), after ≥ 2 lines of systematic therapy. 

The FDA granted this approval based on the results of the open-label, multicenter, single-arm NP30179 trial, which enrolled 132 patients with R/R DLBCL, not otherwise specified (80%) or LBCL arising from FL (20%) and aimed to assess the efficacy and safety of glofitamab-gxbm among these patients. All eligible patients had received a median of 3 lines of systemic therapy. 

Results of this trial indicated an overall response rate of 56% (95% confidence interval [CI]), which 43% of patients achieving complete responses. Among responders, the median duration of response was 18.4 months at a median follow-up of 11.6 months. The 9-month Kaplan Meier estimate for the duration of response was 68.5%, and the median time to response was 42 days. In this trial, the efficacy outcome measures were determined using the 2014 Lugano criteria. 

In total, 145 patients with R/R LBCL were evaluated for safety. The incidence of cytokine release syndrome was reported in 70% of these patients, with grade ≥ 3 cytokine release syndrome observed in 4.1% of cases, immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 4.8%, serious infections in 16%, and tumor flare in 12%.

The most common adverse reactions were cytokine release syndrome, musculoskeletal pain, rash, and fatigue. The most common grade 3 to 4 laboratory abnormalities were decreased lymphocyte counts, phosphate, neutrophil counts, and fibrinogen, as well as an increase in uric acid.

Source: 

FDA grants accelerated approval to glofitamab-gxbm for selected relapsed or refractory large B-cell lymphomas. US Food and Drug Administration; Published online June 16, 2023. Accessed June 22, 2023. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-glofitamab-gxbm-selected-relapsed-or-refractory-large-b-cell