Brand Name

Epkinly

Generic Name
Epcoritamab-Bysp
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FDA approval date: May 19, 2023
Classification: Bispecific CD20-directed CD3 T Cell Engager
Form: Injection

What is Epkinly (Epcoritamab-Bysp)?

EPKINLY is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma , not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. EPKINLY is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma , not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.