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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.
References
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What is your preferred therapy class when planning treatment for a patient with R/R DLBCL after 2 or more lines of systemic therapy ?