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AbbVie: FDA To Review BLA For Epcoritamab


(RTTNews) – 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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