The Korean Ministry of Food and Drug Safety approves glofitamab for patients with R/R DLBCL

On December 8, 2023, the Korean Ministry of Food and Drug Safety approved glofitamab, a bispecific monoclonal antibody for the treatment of patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after ≥2 lines of systemic therapy. This decision is based on promising results from the phase I/II NP30179 trial (NCT03075696).¹

NP30179 trial

NP30179 is a phase I/II open-label study evaluating glofitamab in patients with R/R DLBCL after ≥2 lines of systemic therapy.¹ The Lymphoma Hub previously reported the trial design and promising results (Figure 1).

Figure 1. NP30179 trial outcomes in patients with R/R DLBCL (n = 155)*

CR, complete response; DLBCL, diffuse large B-cell lymphoma; ORR, overall response rate; R/R, relapsed/refractory.
*Adapted from Korea Biomedical Review.¹

 The most common adverse event was cytokine release syndrome occurring in 63%.

Conclusion

The approval of glofitamab in Korea provides patients with R/R DLBCL another treatment option that could benefit the rise in cases of DLBCL currently observed in Korea.