Saturday, April 20, 2024

AbbVie’s TEPKINLY Becomes First Subcutaneous Bispecific Antibody Approved as Monotherapy for Relapsed or Refractory DLBCL

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AbbVie has secured conditional marketing authorization from the European Commission (EC) for TEPKINLY® (epcoritamab), a groundbreaking milestone in the world of lymphoma treatment. TEPKINLY is now the first and sole subcutaneous bispecific antibody approved as a monotherapy specifically tailored for adult patients facing relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after undergoing two or more rounds of systemic therapy.

This historic approval signifies a critical advancement in the field of DLBCL treatment, where options are often limited for patients who have already exhausted multiple lines of therapy. The European Commission’s decision is underpinned by compelling data from the Phase 1/2 EPCORE™ NHL-1 clinical trial. Among DLBCL patients treated with TEPKINLY, an impressive overall response rate of 62 percent and a complete response rate of 39 percent were achieved, with a median response duration of 15.5 months.

TEPKINLY, a T-cell-engaging bispecific antibody, is poised to bring hope and potential breakthroughs to a patient population grappling with a challenging medical journey. It addresses an unmet medical need, where the benefits of immediate availability to patients outweigh limited data availability, emphasizing the urgency and significance of this authorization.

AbbVie’s commitment to pioneering innovative therapies for hematological cancers is further underscored by this achievement. TEPKINLY’s approval as a monotherapy for relapsed or refractory DLBCL is a transformative development that promises improved outcomes for those in need. This noteworthy milestone positions TEPKINLY as a beacon of hope for a condition where few alternatives exist, representing a beacon of hope for the DLBCL patient community.

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