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AbbVie: FDA To Review BLA For Epcoritamab - Quick Facts

AbbVie (ABBV) announced the FDA has accepted for priority review the Biologics License Application for epcoritamab, an investigational subcutaneous bispecific antibody, for the treatment of adult patients with relapsed/refractory large B-cell lymphoma after two or more lines of systemic therapy. Epcoritamab is being co-developed by AbbVie and Genmab as part of oncology collaboration.

The company noted that its application is supported by data from EPCORE NHL-1 Phase 1/2 trial evaluating the safety and preliminary efficacy of subcutaneous epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin's lymphoma, including large B-cell lymphoma.

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