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BLA for Subcutaneous Epcoritamab in LBCL Granted FDA Priority Review

lbcl

The U.S. Food and Drug Administration (FDA) approved a priority review of the Biologics License Application (BLA) for subcutaneous epcoritamab, an investigational bispecific antibody, in the treatment of patients with relapsed/refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.


The BLA submission is based on safety and preliminary efficacy data from the LBCL cohort of the EPCORE NHL-1 open-label, multi-center phase II clinical trial evaluating epcoritamab in patients with relapsed, progressive, or refractory CD20-positive mature B-cell non-Hodgkin lymphoma.

The FDA set a target action date of May 21, 2023, according to the manufacturer of the drug.

Source: BusinessWire, November 2022

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