Glofitamab receives FDA approval for R/R DLBCL

On June 16, 2023, it was announced that the U.S. Food and Drug Administration (FDA) has granted approval to glofitamab, a T cell-engaging bispecific antibody, for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) post prior therapy, including chimeric antigen receptor (CAR) T-cell therapy.¹

Glofitamab is the first CD20×CD3 T cell-engaging bispecific antibody approved for the treatment of patients with R/R DLBCL given for a fixed time period.¹ The accelerated approval from the FDA was based on results from a phase I/II study (NCT03075696) investigating glofitamab as a fixed course in 132 patients for 8.5 months. The patients in this cohort had relapsed or were refractory from prior lines of therapy, including ~30% who had received CAR T-cell therapy. Patients achieved a durable remission after fixed-duration glofitamab treatment (Table 1).¹

Table 1. Primary and secondary endpoints*

CI, confidence interval; NE, not estimable. *Data from Business Wire.1
Endpoint	Patients treated with glofitamab
Overall response, % (95% CI)	56 (47–65)
Complete response, % (95% CI)	43 (35–52)
Median duration of response, years (95% CI)	1.5 (11.4–NE)
Continued to respond for ≥9 months, % (95% CI)	68.5 (56.7–80.3)

The safety profile was also manageable; the most common adverse event reported was cytokine release syndrome in 70% of patients (52% Grade 1 and 14% Grade 2), followed by musculoskeletal pain (21%), fatigue (20%) and rash (20%).¹