Glofitamab-gxbm approved for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified or large B-cell lymphoma arising from follicular lymphoma, after two or more lines of systemic therapy.

Trade name Columvi.

The approval was based on findings from the phase 1/2 trial 2 in which glofitamab, a T-cell engaging bispecific antibody, demonstrated a 56% overall response rate (ORR) and a complete response (CR) rate of 43%. 

Moreover, 68.5% of patients who achieved a response continued to respond for 9 months or longer (95% CI, 56.7-80.3). 

The median duration of response was 18.4 months.

Seven days prior to glofitamab therapy, patients are pretreated with a single dose of obinutuzumab (Gazyva). 

Patients also received a corticosteroid, antipyretic, and an antihistamine as pretreatment to reduce the risk of cytokine release syndrome (CRS).

Glofitamab is then administered in 13 intravenous infusions over up to 12 cycles, which includes step-up dosing, until disease progression or intolerance. 

Following cycle 1 of treament, glofitamab is given once every 3 weeks.

In the multicenter, open-label, dose-escalation, and dose-expansion trial, glofitamab was administered as a fixed course for 8.5 months in 132 patients with DLBCL who were relapsed or refractory to prior treatment; 30% of patients had received prior CAR T-cell therapy and 83% were refractory to their most recent treatment.

The most common adverse events were CRS (70%), musculoskeletal pain (21%), fatigue (20%) and rash (20%). CRS was found to be mostly low grade at grade 1 (52%) and grade 2 (14%).