Pharma Focus Asia

Genmab Announces Approval of EPKINLYTM to Treat Relapsed or Refractory Large B-Cell Lymphoma

Tuesday, September 26, 2023

Genmab announced the approval of EPKINLYTM (epcoritamab) by the Japan Ministry of Health, Labour and Welfare, marking a significant advancement in the treatment of certain types of relapsed/refractory (R/R) large B-cell lymphoma (LBCL) in adult patients who have undergone two or more lines of systemic therapy.

Epcoritamab is a bispecific antibody of the IgG1 class, developed using Genmab's proprietary DuoBody® technology. This technology, specifically DuoBody-CD3, is engineered to selectively direct cytotoxic T cells to target specific cell types, triggering an immune response. 

EPKINLY is designed to bind to CD3 on T cells and CD20 on B cells. This unique dual binding capability enables EPKINLY to induce T-cell mediated killing of CD20+ cells, primarily B cells.

The approval of EPKINLY in Japan is based on the results from two open-label, multi-centre studies that were specifically designed to assess the safety and initial effectiveness of EPKINLY when administered as monotherapy in patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL).

The approval of EPKINLY in Japan addresses a significant unmet medical need, offering a new therapeutic option for adult patients with R/R LBCL who have exhausted other treatment options. 

Despite advancements in LBCL treatment, the prognosis for patients with relapsed or refractory LBCL remains generally poor. EPKINLY's innovative mechanism of action and administration via subcutaneous injection provide hope for improved outcomes in this challenging medical condition.

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